HL

Cue Health

- NASDAQ:HLTH
Last Updated 2022-11-25

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Track Cue Health hiring and firing trends, filtered by title, location, type, date, category and date of posting.
Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Salary Salary Currency Salary Description Coordinates Date Added Date Updated Company Name Sector Industry
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 5th, 2022 12:00AM Validation Engineer, Quality Engineering Open Cue Health Inc. Moda South USA May 6th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p><span><span><span>Cue Health Inc. has an opening for a<span> </span></span><b>Validation Engineer, Quality Engineering<span> </span></b>to partner with our Product Development and Manufacturing team’s initiatives and maintain QMS compliance with the applicable Standards and Regulations.<b><span> </span></b>Under the guidance of the Manager, Quality Engineering, t<span>he Validation Engineer, Quality Engineering, fulfills a critical role in GMP and GLP operations. This individual must plan, write and execute Engineering studies and validation protocols, reports and other technical documents, as well as conduct validation related investigation<span> </span></span>for our laboratories and manufacturing processes, rooms and equipment. This position requires knowledge of process validation principals, manufacturing controls, and their application to Medical device/IVD standard requirements.</span></span></p><p></p><p></p><p><span><span><b>Responsibilities:</b></span></span></p><ul><li><p><span><span>Work in compliance with Cue Health’s Quality Management System requirements</span></span></p></li><li><p><span><span>Plan and execute commissioning and validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports</span></span></p></li><li><p><span><span>Prepare and/or review functional and design specifications, engineering studies, validation protocols (IQ/OQ/PQ), validation reports and manufacturing documents (standard operating procedures, work instructions, etc.)</span></span></p></li><li><p><span><span>Execution of test protocols, including identification and resolution of non-conformances / deviations</span></span></p></li><li><p><span><span>Program and use data loggers for executions of validation protocols</span></span></p></li><li><p><span><span>Support processes, rooms and equipment improvement projects that require validation support</span></span></p></li><li><p><span><span>Perform functional and process risk assessments in conjunction with Quality, Operations and Engineering subject matter experts</span></span></p></li><li><p><span><span>Perform and document statistical analysis related to validations</span></span></p></li><li><p><span><span>Coordinate with end users and process owners to lead development of validation strategy for projects, systems, and processes. These projects may span sustaining manufacturing and laboratories, the introduction of new processes, rooms and equipment, and/or improvements</span></span></p></li><li><p><span><span>Protocols may consist of any of the following: hvac, facilities, utilities, temperature chambers, environmental mapping, and/or mechanical systems</span></span></p></li><li><p><span><span>Review and approve validation protocols and reports provided by internal teams or third party suppliers (consultants, equipment / instrument manufacturers, etc.)</span></span></p></li><li><p><span><span>Train Operations or laboratory staff on protocols, procedures and technical details related to systems, equipment</span></span></p></li><li><p><span><span>Provide consultation to other departments performing validation activities</span></span></p></li><li><p><span><span>Manage contractors supporting validation projects</span></span></p></li><li><p><span><span>Manage validation equipment in compliance with Quality System Requirements</span></span></p></li><li><p><span><span>Learn and understand the applicable technologies and engage in technical discussions. Act as a subject matter expert for validation discussions</span></span></p></li><li><p><span><span>Identify areas and opportunities to improve manufacturing facilities, processes, and equipment</span></span></p></li><li><p><span><span>Other duties as assigned</span></span></p></li></ul><p></p><p><span><span><b>Requirements:</b></span></span></p><ul><li><p><span><span>Bachelor’s degree in biochemical engineering, mechanical engineering, industrial engineering, or equivalent</span></span></p></li><li><p><span><span><b>5&#43;</b><span> </span>years of validation experience in a biotech, medical device, IVD or pharmaceutical product manufacturing environment</span></span></p></li><li><p><span><span>Strong knowledge and working application of validation principles, regulatory agency guidelines and standard industry practices</span></span></p></li><li><p><span><span>Knowledge and working application of FDA, ISO 13485 and cGMP requirements</span></span></p></li><li><p><span><span>Experience in the biotech, medical device, IVD and/or pharmaceutical industry in the development and deployment of manufacturing processes, process controls, and continuous improvement methods</span></span></p></li><li><p><span><span>Ability to deliver results under minimum supervision to accomplish goals while working across departments is required</span></span></p></li><li><p><span><span>Demonstrated strong analytical problem solving and team collaboration skills</span></span></p></li><li><p><span><span>Excellent interpersonal, written, and verbal communication skills</span></span></p></li><li><p><span><span>Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc. to perform critical job functions, trending, reporting metrics, etc.</span></span></p></li><li><p><span><span>Adaptable to fast-paced, dynamic work environment with ability to methodically manage projects</span></span></p></li></ul><p></p><p><b>Environment and Physical Activities/Requirements:</b></p><p></p><ul><li><p>You will work in an indoor <b>office</b> environment for which no adverse conditions are expected.  This position requires the following physical activities and/or requirements:</p><ul><li><p>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</p></li><li><p>Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers</p></li><li><p>Communicating with others to exchange information</p></li><li><p>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 20 pounds</p></li></ul></li></ul><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 4th, 2022 11:14PM Jun 4th, 2022 11:14PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 5th, 2022 12:00AM Scientist, R&D Molecular (Weekend Nights) Open Cue Health Inc. Moda North USA May 6th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p><span>Cue Health Inc.  is seeking to hire a full-time<b> Scientist, R&amp;D Molecular</b>.  We are looking for a talented, enthusiastic, highly motivated Scientist to join the R&amp;D team and contribute to the development of new products for a medical diagnostic device.    You will play a key role supporting sample acquisition and characterization, inventory management, and new assay development. The ideal candidate needs to have hands-on lab experience, good organizational skills, display a proactive attitude and be flexible about their activities.  </span></p><p></p><p><b><span>Responsibilities:</span></b></p><p></p><ul><li><p><span>Inventory Management, including sample acquisition, and characterization of live pathogens and clinical samples in a BSL 2 lab</span></p></li><li><p><span>Execute nucleic acid extraction and analytical assays</span></p></li><li><p><span>Design and execute RT-PCR/ddPCR and NGS assays</span></p></li><li><p><span>Execute experiments to test cartridges, including cartridge preparation and autopsy</span></p></li><li><p><span>Write verification and validation study protocols and reports</span></p></li><li><p><span>Facilitate optimization of assay conditions to achieve commercial levels of stability and performance</span></p></li><li><p><span>Troubleshoot problems and identify solutions to technical challenges</span></p></li><li><p><span>Conduct clear and concise communication with colleagues (cross-functional) and supervisors through oral updates, written reports, and technical meetings</span></p></li></ul><p></p><p><b><span>Requirements:</span></b></p><p></p><ul><li><p><span>MS or PhD Bioengineering, Biochemical Engineering, Biomedical Engineering, Applied Biotechnology, or related field.</span></p></li><li><p><span>5&#43; years of relative work in applying fundamental scientific principles to the design, verification and validation of Immunoassay and/or molecular amplification diagnostics</span></p></li><li><p><span>Excellent communication and collaboration skills</span></p></li><li><p><span>Extremely detail oriented with excellent hands-on laboratory and experimental skills</span></p></li><li><p><span>Proven level of high technical proficiency and initiative</span></p></li><li><p><span>Aptitude to understand mechanical failures in diagnostic cartridges</span></p></li><li><p><span>Background in a science or engineering discipline with knowledge of manufacturing processes</span></p></li><li><p><span>Experience in the medical device industry is a plus</span></p></li><li><p><span>Experience in taking products from feasibility through commercial launch is preferable</span></p></li></ul><p></p><p><b>Environment and Physical <span>Activities/Requirements:</span></b></p><p></p><ul><li><p>You will work in an indoor <b>laboratory</b> environment, which may occasionally be noisy, subject to climate and humidity requirements, and hazardous substances.  This position requires the following physical activities and/or requirements:</p><ul><li><p>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</p></li><li><p>Moving about to accomplish tasks or moving from one worksite to another, including possibly tight or confined spaces</p></li><li><p>Reaching, crouching, or stooping</p></li><li><p>Repeating motions that may include the wrists, hands, and/or fingers</p></li><li><p>Gross and/or fine manipulation of items with hands and fingers</p></li><li><p>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 50 pounds</p></li><li><p>Operating machinery and/or heavy laboratory equipment</p></li><li><p>Communicating with others to exchange information</p></li><li><p>Visual acuity (far and near), including peripheral vision</p></li></ul></li></ul><p>#LI-RR1</p><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 4th, 2022 11:14PM Jun 4th, 2022 11:14PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 5th, 2022 12:00AM Scientist, R&D Molecular Open Cue Health Inc. Moda North USA May 6th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p><span>Cue Health Inc.  is seeking to hire a full-time<b> Scientist, R&amp;D Molecular</b>.  We are looking for a talented, enthusiastic, highly motivated Scientist to join the R&amp;D team and contribute to the development of new products for a medical diagnostic device.    You will play a key role supporting sample acquisition and characterization, inventory management, and new assay development. The ideal candidate needs to have hands-on lab experience, good organizational skills, display a proactive attitude and be flexible about their activities.  </span></p><p></p><p><b><span>Responsibilities:</span></b></p><p></p><ul><li><p><span>Inventory Management, including sample acquisition, and characterization of live pathogens and clinical samples in a BSL 2 lab</span></p></li><li><p><span>Execute nucleic acid extraction and analytical assays</span></p></li><li><p><span>Design and execute RT-PCR/ddPCR and NGS assays</span></p></li><li><p><span>Execute experiments to test cartridges, including cartridge preparation and autopsy</span></p></li><li><p><span>Write verification and validation study protocols and reports</span></p></li><li><p><span>Facilitate optimization of assay conditions to achieve commercial levels of stability and performance</span></p></li><li><p><span>Troubleshoot problems and identify solutions to technical challenges</span></p></li><li><p><span>Conduct clear and concise communication with colleagues (cross-functional) and supervisors through oral updates, written reports, and technical meetings</span></p></li></ul><p></p><p><b><span>Requirements:</span></b></p><p></p><ul><li><p><span>MS or PhD Bioengineering, Biochemical Engineering, Biomedical Engineering, Applied Biotechnology, or related field.</span></p></li><li><p><span>5&#43; years of relative work in applying fundamental scientific principles to the design, verification and validation of Immunoassay and/or molecular amplification diagnostics</span></p></li><li><p><span>Excellent communication and collaboration skills</span></p></li><li><p><span>Extremely detail oriented with excellent hands-on laboratory and experimental skills</span></p></li><li><p><span>Proven level of high technical proficiency and initiative</span></p></li><li><p><span>Aptitude to understand mechanical failures in diagnostic cartridges</span></p></li><li><p><span>Background in a science or engineering discipline with knowledge of manufacturing processes</span></p></li><li><p><span>Experience in the medical device industry is a plus</span></p></li><li><p><span>Experience in taking products from feasibility through commercial launch is preferable</span></p></li></ul><p></p><p><b>Environment and Physical <span>Activities/Requirements:</span></b></p><p></p><ul><li><p>You will work in an indoor <b>laboratory</b> environment, which may occasionally be noisy, subject to climate and humidity requirements, and hazardous substances.  This position requires the following physical activities and/or requirements:</p><ul><li><p>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</p></li><li><p>Moving about to accomplish tasks or moving from one worksite to another, including possibly tight or confined spaces</p></li><li><p>Reaching, crouching, or stooping</p></li><li><p>Repeating motions that may include the wrists, hands, and/or fingers</p></li><li><p>Gross and/or fine manipulation of items with hands and fingers</p></li><li><p>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 50 pounds</p></li><li><p>Operating machinery and/or heavy laboratory equipment</p></li><li><p>Communicating with others to exchange information</p></li><li><p>Visual acuity (far and near), including peripheral vision</p></li></ul></li></ul><p>#LI-RR1</p><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 4th, 2022 11:14PM Jun 4th, 2022 11:14PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 5th, 2022 12:00AM Senior Systems Administrator Open Cue Health Inc. Remote - CA USA May 6th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p><span> </span>Cue Health is seeking to hire a full-time <b>Senior Systems Administrator.</b></p><p></p><p><b>Responsibilities:</b></p><p></p><ul><li><p>Provide project leadership to cross-functional team members as well as oversight and mentorship to less experienced staff as assigned  </p></li><li><p>Work with stakeholders to integrate systems to include Okta SSO and SCIM with SaaS, cloud and on prime applications, while minimizing the impact on business</p></li><li><p>Work with the HRIS/Workday team supporting our integration between Workday and Okta</p></li><li><p>Refine and improve Onboarding and Offboarding workflows and automation</p></li><li><p>Lead initiative to identify application assignments based on department and role</p></li><li><p>Manage push groups and integrations with applications such as Google Workspace, Active Directory and Workday</p></li><li><p>Strong understanding of automation tools and scripting languages such as PowerShell</p></li><li><p>Develops automation scripts and evaluates current technology tools to streamline the repetitive activities to build IaaS platform</p></li><li><p>Performs troubleshooting and issue resolution and escalate issues to appropriate 3rd party vendor as needed.</p></li><li><p>Manage internal DHCP, DNS Servers, Network Storage, and Core Network Hardware</p></li><li><p>Act as an Automation Architect to provide the solutions for self-provisioning systems, systems maintenance, and monitoring systems</p></li><li><p>Apply experience with Infrastructure, Automation Tools and Cloud management</p></li><li><p>Managing multiple projects simultaneously</p></li><li><p>Communicating complex information and provide training to a non-technological audience</p></li><li><p>Assist with software installs, including automation scripting as needed</p></li><li><p>Responsible for documenting the systems infrastructure, procedures and maintaining an accurate hardware and software inventory</p></li><li><p>Additional duties as assigned</p></li></ul><p></p><p><b>Requirements:</b></p><p></p><ul><li><p>8&#43; years of relevant, hands-on IT experience and to include leadership of project teams.  Prior staff supervisory experience strongly preferred</p></li><li><p>Bachelor&#39;s Degree in Computer Engineering or related field, or equivalent experience</p></li><li><p>Experience with Infrastructure, Automation Tools and Cloud management</p></li><li><p>Experience in related tools (InTune or other MDM, SSO/SAML, NetSuite, Panorama &amp; GPA, ManageEngine, Unifi/Cisco/Vyatta Controller, etc.)</p></li><li><p>Experience with user provisioning and lifecycle management within Okta and integrated applications (Workday, Slack, box, Gworkspace, Jira and other applications)</p></li><li><p>Proficiency in Scripting Languages such as PowerShell, and OKTA workflow</p></li><li><p>Technically proficiencyt with Google Cloud Platform, Google Workspace (GSuite), AWS, and O365</p></li><li><p>Experience with Jira and Confluence (or similar) for issue reporting &amp; project tracking</p></li><li><p>Hands-on experience working on Virtual Technologies (VMware, Hypervisor, etc)</p></li><li><p>Expert level experience with AD/ADFS, Azure AD, LDAP, JumpCloud, OKTA and other IDPs</p></li><li><p>Available for on-call support after core business hours and on weekends</p></li><li><p>Although this position is anticipated to be remote-based, must have ability to travel to onsite locations as needed with sufficient notice.</p></li></ul><p></p><p></p><p></p><p><b>Environment and Physical Activities/Requirements:</b></p><p></p><ul><li><p>You will work in an indoor <b>remote</b> environment for which no adverse conditions are expected.  This position requires the following physical activities and/or requirements:</p><ul><li><p>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</p></li><li><p>Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers</p></li><li><p>Communicating with others to exchange information</p></li><li><p>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 20 pounds</p></li></ul></li></ul><p>#LI-DH1</p><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 4th, 2022 11:14PM Jun 4th, 2022 11:14PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 5th, 2022 12:00AM Research Technician Open Cue Health Inc. Waples USA May 6th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p>Cue Health Inc. has an opening for a <b>Research Technician </b>to perform laboratory manufacturing processes according to GMP documentation.</p><p></p><p><b>Responsibilities: </b></p><ul><li><p>Preparation of general lab stock solutions/buffers. Responsible for aliquoting and labeling.</p></li><li><p>Under supervision, performs quality analysis of reagents, components, and finished products in accordance with SOPs and work instructions</p></li><li><p>Conduct validation studies and shelf life studies as assigned</p></li><li><p>Assists with scale up activities (protocol/report documentation, study execution)</p></li><li><p>Updates documentation such as standard operating procedures (SOP), Work Instructions, and Lot History Records as needed</p></li><li><p>Document experimental data, presenting data, conclusions and interpretations</p></li></ul><ul><li><p>Follow established protocols and good laboratory practices</p></li><li><p>Review operations documentation for technical content, accuracy, and completion in accordance with GMP</p></li><li><p>Assist with transfer documentation such as material specifications, equipment qualifications, work instructions, and quality control procedures as needed</p></li><li><p>Work in both standard and clean room environments while adhering to room specific PPE requirements</p></li><li><p>Effectively communicate and interface with work groups to ensure the completion of daily production</p></li><li><p>May require exposure to fumes, chemicals, cold, noise, radiation, blood/body fluids, and infectious diseases</p></li></ul><p></p><p><b>Requirements: </b></p><ul><li><p>Bachelor’s degree BS (or AS &#43; relevant experience) in Biology, Chemistry, Biochemistry, Molecular Biology or other related life science discipline</p></li><li><p>1-3 Years’ experience</p></li><li><p>Experience in GMP and ISO environment is preferred</p></li><li><p>Experience in completing documentation (GDP) and data collection in a GMP laboratory preferred</p></li><li><p>Experience in the medical device and/or biotechnology industry is preferred</p></li></ul><p></p><p><b>Environment and Physical Activities/Requirements:</b></p><p></p><ul><li><p>You will work in an indoor <b>laboratory</b> environment, which may occasionally be noisy, subject to climate and humidity requirements, and hazardous substances.  This position requires the following physical activities and/or requirements:</p><ul><li><p>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</p></li><li><p>Moving about to accomplish tasks or moving from one worksite to another, including possibly tight or confined spaces</p></li><li><p>Reaching, crouching, or stooping</p></li><li><p>Repeating motions that may include the wrists, hands, and/or fingers</p></li><li><p>Gross and/or fine manipulation of items with hands and fingers</p></li><li><p>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 50 pounds</p></li><li><p>Operating machinery and/or heavy laboratory equipment</p></li><li><p>Communicating with others to exchange information</p></li><li><p>Visual acuity (far and near), including peripheral vision</p></li></ul></li></ul><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 4th, 2022 11:14PM Jun 4th, 2022 11:14PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 5th, 2022 12:00AM Senior Quality Engineer, Validation Open Cue Health Inc. Moda South USA May 6th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p>Cue Health Inc. has an opening for a <b>Senior Validation Engineer, Quality </b>to partner with our Product Development and Manufacturing team’s initiatives and maintains QMS compliance with the applicable Standards and Regulations. Under the guidance of the Manager, Quality Engineering, the Senior Validation Engineer, Quality, fulfills a critical role in GMP and GLP operations. This individual must plan, write and execute Engineering studies and validation protocols, reports and other technical documents, as well as conduct validation related investigation for our laboratories and manufacturing processes, rooms and equipment. This position requires knowledge of process validation principals, manufacturing controls, and their application to Medical device/IVD standard requirements.</p><p></p><p><b>Responsibilities: </b></p><ul><li><p>Work in compliance with Cue Health’s Quality Management System requirements</p></li><li><p>Plan and execute commissioning and validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports</p></li><li><p>Prepare and/or review functional and design specifications, engineering studies, validation protocols (IQ/OQ/PQ), validation reports and manufacturing documents (standard operating procedures, work instructions, etc.)</p></li><li><p>Execution of test protocols, including identification and resolution of non-conformances / deviations</p></li><li><p>Program and use data loggers for executions of validation protocols</p></li><li><p>Support processes, rooms and equipment improvement projects that require validation support</p></li><li><p>Perform functional and process risk assessments in conjunction with Quality, Operations and Engineering subject matter experts</p></li><li><p>Perform and document statistical analysis related to validations</p></li><li><p>Coordinate with end users and process owners to lead development of validation strategy for projects, systems, and processes. These projects may span sustaining manufacturing and laboratories, the introduction of new processes, rooms and equipment, and/or improvements</p></li><li><p>Protocols may consist of any of the following: HVAC, facilities, utilities, temperature chambers, environmental mapping, and/or mechanical systems</p></li><li><p>Review and approve validation protocols and reports provided by internal teams or third party suppliers (consultants, equipment / instrument manufacturers, etc.)</p></li><li><p>Train Operations or laboratory staff on protocols, procedures and technical details related to systems, equipment</p></li><li><p>Provide consultation to other departments performing validation activities</p></li><li><p>Manage contractors supporting validation projects</p></li><li><p>Manage validation equipment in compliance with Quality System Requirements</p></li><li><p>Learn and understand the applicable technologies and engage in technical discussions. Act as a subject matter expert for validation discussions</p></li><li><p>Identify areas and opportunities to improve manufacturing facilities, processes, and equipment</p></li><li><p>Other duties as assigned</p></li></ul><p></p><p><b>Requirements: </b></p><ul><li><p>Bachelor’s degree in biochemical engineering, mechanical engineering, industrial engineering, or equivalent</p></li><li><p><b>7&#43;</b> years of validation experience in a biotech, medical device, IVD or pharmaceutical product manufacturing environment</p></li><li><p>Strong knowledge and working application of validation principles, regulatory agency guidelines and standard industry practices.</p></li><li><p>Knowledge and working application of FDA, ISO 13485 and cGMP requirements</p></li><li><p>Experience in the biotech, medical device, IVD and/or pharmaceutical industry in the development and deployment of manufacturing processes, process controls, and continuous improvement methods</p></li><li><p>Ability to deliver results under minimum supervision to accomplish goals while working across departments is required</p></li><li><p>Demonstrated strong analytical problem solving and team collaboration skills</p></li><li><p>Excellent interpersonal, written, and verbal communication skills</p></li><li><p>Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc. to perform critical job functions, trending, reporting metrics, etc.</p></li><li><p>Adaptable to fast-paced, dynamic work environment with ability to methodically manage projects</p></li></ul><p></p><p></p><p><b>Environment and Physical Activities/Requirements:</b></p><p></p><ul><li><p>You will work in an indoor <b>office</b> environment for which no adverse conditions are expected.  This position requires the following physical activities and/or requirements:</p><ul><li><p>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</p></li><li><p>Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers</p></li><li><p>Communicating with others to exchange information</p></li><li><p>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 20 pounds</p></li></ul></li></ul><p></p><p></p><p></p><p></p><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 4th, 2022 11:14PM Jun 4th, 2022 11:14PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 5th, 2022 12:00AM Manager Validation and Quality Engineering Open Cue Health Inc. Moda South USA May 6th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p>Cue Health Inc. is looking for a full-time <b>Manager, Validation and Quality Engineering.  </b>Reporting to the Director, Quality Operations, the Manager of Validation and Quality Engineering will provide technical expertise for the projects, functions, and strategic objectives of the manufacturing process validation and verification, equipment and facility validation, Sustaining Quality and non product/ Quality system software validation   Groups, concentrating on managing the Quality Engineering team and supporting complex automated manufacturing systems, enterprise systems, data integration, system integration, engineering and quality documentation development. The position may be responsible for various aspects of management and will require interfacing with all functions (Information Technology, Quality Assurance, Operations, Engineering, R&amp;D, Regulatory Affairs, Marketing, Legal, Customer Operations, upper levels of management, vendors, and contract manufacturers).</p><p></p><p><b>Responsibilities: </b></p><p></p><ul><li><p>Manage the Validation/ Quality Engineering team</p></li><li><p>Lead facility and equipment qualification, non product software and manufacturing process validation including governing policies and procedures and associated risk analysis and impact assessments activities</p></li><li><p>Collaborates with other managers in Quality Operations in the establishment, operation, and maintenance of the Quality System</p></li><li><p>Work with cross functional teams to create and/or modify methods and procedures to ensure appropriate process validation and verification methods and tests are conducted</p></li><li><p>Collaborates across functions, leveraging others’ quality and technical expertise to troubleshoot problems, interpret data, determine problem solving steps, and create technical reports</p></li><li><p>Lead and assist in development and documentation of equipment qualification, non-product software and manufacturing process validation  plans, processes, procedures, and work instructions</p></li><li><p>Support other Quality System activities for manufacturing inspection and test, process control, equipment calibration, nonconforming material, corrective and preventive action, quality records, and statistical techniques</p></li><li><p>Perform product failure investigations and facilitate required corrective / preventive actions</p></li><li><p>Works closely with Sr. Manager of Design Quality Engineering to providing support the late phase design activities including design transfer efforts,</p></li><li><p>Responsible for review and approval of change order requests and change plans, risk management plans, hazard analysis and FMEA’s</p></li><li><p>Responsible for compliance and maintenance of Regulatory Standards that apply to maintenance of manufacturing processes, equipment and non product software and systems in a validated and controlled state</p></li><li><p>Manage and actively participate in component, assembly, system, and process IQ, IQ, PQ activities, revalidation and process capability analysis</p></li><li><p>Provide quality support for marketed products including establish and maintain product quality measures, monitor product reliability, and contribute to improvements and support inspection and test activities</p></li><li><p>Produce/maintain metrics and/or reports on all activities as required</p></li><li><p>Perform other quality related tasks to meet company goal as required</p></li><li><p>Support the other Quality leaders with third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities</p></li></ul><ul><li><p>Other duties as assigned</p></li></ul><p></p><p><b>Requirements: </b></p><p></p><ul><li><p>7&#43; years of design, validation and quality engineering experience in the process validation and manufacturing process transfer of medical devices/ diagnostic products and or Biopharmaceuticals.</p></li><li><p>3&#43; year experience in managing Quality assurance, design Quality, validation or Quality Engineer team or equivalent</p></li><li><p>BS / BA in an engineering, biologics or other technical field or equivalent</p></li><li><p>Knowledgeable of Quality system principles; FDA Quality System Regulation (cGMP); IVDD or MDD regulations, ISO 13485 quality system standards. Knowledge on MDSAP and IVDR is a plus</p></li><li><p>Knowledge of ISO14971 Risk Management Systems required. Software  life cycle management and validation experience</p></li><li><p>Strong knowledge of cGMP principles and process validation, non-product software life cycle management  as applied to Medical Device manufacturing</p></li><li><p>Application of statistical techniques for quality assurance</p></li><li><p>Experience in product and manufacturing validation and risk management in a regulated environment, including late phase design control, Risk Management (FTA, PFMEA, hazard analysis, etc.), validation, and process metrics</p></li><li><p>Ability to work with Operations engineers and other functional group personnel to accomplish common goals</p></li><li><p>ASQ Certification is a plus</p></li><li><p>Computer literate in word processing, spreadsheets, databases, and other quality related productivity programs</p></li><li><p>Self-disciplined able to work under minimum supervision in fast paced environment</p></li><li><p>Be flexible on work schedule. Be able to work during weekends or evenings when required.</p></li><li><p>Detail oriented, with good written and verbal communication skills</p></li><li><p>Travel between Cue Health sites required</p></li><li><p>Able to travel up to 5% if required (Domestic and International)</p></li></ul><p></p><p><b>Environment and Physical Activities/Requirements:</b></p><p></p><ul><li><p>You will work in an indoor <b>office</b> environment for which no adverse conditions are expected.  This position requires the following physical activities and/or requirements:</p><ul><li><p>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</p></li><li><p>Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers</p></li><li><p>Communicating with others to exchange information</p></li><li><p>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 20 pounds</p></li></ul></li></ul><p>#LI-AF1</p><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 4th, 2022 11:14PM Jun 4th, 2022 11:14PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 5th, 2022 12:00AM Research Technician, R&D (Weekends) Open Cue Health Inc. Moda North USA May 6th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p>Cue Health Inc. is seeking a talented, enthusiastic, highly motivated <b>Research Technician, R&amp;D </b>to join the R&amp;D team and contribute to the development of new products for a medical diagnostic device. Under guidance, assist the team covering all aspects of assay development from sample preparation and testing to documentation. Perform standard protocols for a variety of methods including but not limited to dilution, aliquoting, PCR, and cartridge testing. The ideal candidate needs to have good organizational skills, display a proactive attitude and be flexible about their activities.</p><p></p><p><b>Position Responsibilities:</b></p><ul><li><p>Conduct test protocols and experimental procedures under supervision</p></li><li><p>Work as a member of a R&amp;D team, as well as on independent projects</p></li><li><p>Excellent organizational skills, able to multi-task, and efficient with hands-on laboratory research</p></li><li><p>Learn to independently troubleshoot problems and identify solutions to technical challenges</p></li><li><p>Analyze and organize data, document, and present results in a timely manner</p></li><li><p>Dilute and aliquot live pathogens and human clinical samples in a BSL 2 lab</p></li><li><p>Execute nucleic acid extraction and analytical assays</p></li><li><p>Execute experiments to test cartridges, including cartridge preparation and autopsy</p></li><li><p>Participate in preparation and execution of verification and validation studies</p></li><li><p>Additional duties as assigned</p></li></ul><p></p><p><b>Requirements:</b></p><ul><li><p>B.S.  in chemistry, biochemistry, molecular biology, or a related discipline</p></li><li><p>Hands on experience with PCR and comprehension of molecular biology techniques</p></li><li><p>Good pipetting skills</p></li><li><p>Understanding of the procedures and record keeping</p></li><li><p>Excellent analytical thinking and problem-solving skills</p></li></ul><p></p><p><b>Physical Requirements:</b></p><ul><li><p>Remaining in a stationary position, often standing or sitting for prolonged period of time</p></li><li><p>Repeating motions that may include the wrists, hands and/or fingers</p></li></ul><p></p><p><span>Yo</span><span>u will work in a </span><b>office</b><span> environment. Your contribution will set the pace and have an impact in the technology, health and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, competitive salary.</span></p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 4th, 2022 11:14PM Jun 4th, 2022 11:14PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 7th, 2022 12:00AM Validation Engineer, Quality Engineering Open Cue Health Inc. Vista, CA USA May 8th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p><span><span><span>Cue Health Inc. has an opening for a<span> </span></span><b>Validation Engineer, Quality Engineering<span> </span></b>to partner with our Product Development and Manufacturing team’s initiatives and maintain QMS compliance with the applicable Standards and Regulations.<b><span> </span></b>Under the guidance of the Manager, Quality Engineering, t<span>he Validation Engineer, Quality Engineering, fulfills a critical role in GMP and GLP operations. This individual must plan, write and execute Engineering studies and validation protocols, reports and other technical documents, as well as conduct validation related investigation<span> </span></span>for our laboratories and manufacturing processes, rooms and equipment. This position requires knowledge of process validation principals, manufacturing controls, and their application to Medical device/IVD standard requirements.</span></span></p><p></p><p></p><p><span><span><b>Responsibilities:</b></span></span></p><ul><li><p><span><span>Work in compliance with Cue Health’s Quality Management System requirements</span></span></p></li><li><p><span><span>Plan and execute commissioning and validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports</span></span></p></li><li><p><span><span>Prepare and/or review functional and design specifications, engineering studies, validation protocols (IQ/OQ/PQ), validation reports and manufacturing documents (standard operating procedures, work instructions, etc.)</span></span></p></li><li><p><span><span>Execution of test protocols, including identification and resolution of non-conformances / deviations</span></span></p></li><li><p><span><span>Program and use data loggers for executions of validation protocols</span></span></p></li><li><p><span><span>Support processes, rooms and equipment improvement projects that require validation support</span></span></p></li><li><p><span><span>Perform functional and process risk assessments in conjunction with Quality, Operations and Engineering subject matter experts</span></span></p></li><li><p><span><span>Perform and document statistical analysis related to validations</span></span></p></li><li><p><span><span>Coordinate with end users and process owners to lead development of validation strategy for projects, systems, and processes. These projects may span sustaining manufacturing and laboratories, the introduction of new processes, rooms and equipment, and/or improvements</span></span></p></li><li><p><span><span>Protocols may consist of any of the following: hvac, facilities, utilities, temperature chambers, environmental mapping, and/or mechanical systems</span></span></p></li><li><p><span><span>Review and approve validation protocols and reports provided by internal teams or third party suppliers (consultants, equipment / instrument manufacturers, etc.)</span></span></p></li><li><p><span><span>Train Operations or laboratory staff on protocols, procedures and technical details related to systems, equipment</span></span></p></li><li><p><span><span>Provide consultation to other departments performing validation activities</span></span></p></li><li><p><span><span>Manage contractors supporting validation projects</span></span></p></li><li><p><span><span>Manage validation equipment in compliance with Quality System Requirements</span></span></p></li><li><p><span><span>Learn and understand the applicable technologies and engage in technical discussions. Act as a subject matter expert for validation discussions</span></span></p></li><li><p><span><span>Identify areas and opportunities to improve manufacturing facilities, processes, and equipment</span></span></p></li><li><p><span><span>Other duties as assigned</span></span></p></li></ul><p></p><p><span><span><b>Requirements:</b></span></span></p><ul><li><p><span><span>Bachelor’s degree in biochemical engineering, mechanical engineering, industrial engineering, or equivalent</span></span></p></li><li><p><span><span><b>4&#43;</b><span> </span>years of validation experience in a biotech, medical device, IVD or pharmaceutical product manufacturing environment</span></span></p></li><li><p><span><span>Strong knowledge and working application of validation principles, regulatory agency guidelines and standard industry practices</span></span></p></li><li><p><span><span>Knowledge and working application of FDA, ISO 13485 and cGMP requirements</span></span></p></li><li><p><span><span>Experience in the biotech, medical device, IVD and/or pharmaceutical industry in the development and deployment of manufacturing processes, process controls, and continuous improvement methods</span></span></p></li><li><p><span><span>Ability to deliver results under minimum supervision to accomplish goals while working across departments is required</span></span></p></li><li><p><span><span>Demonstrated strong analytical problem solving and team collaboration skills</span></span></p></li><li><p><span><span>Excellent interpersonal, written, and verbal communication skills</span></span></p></li><li><p><span><span>Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc. to perform critical job functions, trending, reporting metrics, etc.</span></span></p></li><li><p><span><span>Adaptable to fast-paced, dynamic work environment with ability to methodically manage projects</span></span></p></li></ul><p></p><p><b>Environment and Physical Activities/Requirements:</b></p><p></p><ul><li><p>You will work in an indoor <b>office</b> environment for which no adverse conditions are expected.  This position requires the following physical activities and/or requirements:</p><ul><li><p>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</p></li><li><p>Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers</p></li><li><p>Communicating with others to exchange information</p></li><li><p>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 20 pounds</p></li></ul></li></ul><p>#LI-AF1</p><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 6th, 2022 08:18PM Jun 6th, 2022 08:18PM
nasdaq:hlth cuehealth.wd1.myworkdayjobs.com cuehealth.wd1.myworkdayjobs.com Jun 7th, 2022 12:00AM Staff Software Test Engineer Open Cue Health Inc. Remote - CA USA May 8th, 2022 12:00AM <p><b>About Us</b>:</p><p></p><p><span>Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit </span><a href="http://www.cuehealth.com/" target="_blank"><span>www.cuehealth.com</span></a><span>. </span></p><p></p><p><span>Cue Health Inc. is seeking to hire a full-time <b>Staff</b> <b>Software Test Engineer.</b>  The Software Test Engineer plays a key role in the development of all our new products and features.  As part of our agile team a successful candidate will use a variety of testing methodologies to validate new features and perform regression testing on the existing systems.  The person in this role is responsible for testing mobile and web apps and will be responsible for software validation testing cycle and ensure high expectations of our device.</span></p><p></p><p><b><span>Responsibilities:</span></b></p><ul><li><p><span>Create, modify and execute tests (including ad-hoc and interoperability) for <b>mobile and web apps</b></span></p></li><li><p><span>Understand software requirements, write test plans and other test documentation as required</span></p></li><li><p><span>Regress, isolate and report issues found during manual and automated testing</span></p></li><li><p><span>Lead scrum test teams and coordinate release trains for certifying software release candidates</span></p></li><li><p><span>Be a vocal proponent for quality in every phase of the development process and knowledgeable of medical device regulatory standards such as IEC 62304</span></p></li><li><p><span>Creating and writing guidelines for testing new products as it pertains to software as a medical device (SaMD) and Class I/II systems</span></p></li><li><p><span>Writing programs and scripts as necessary to automate the software testing</span></p></li><li><p><span>Work closely with the<u> different software </u>team members (Firmware, Mobile App, Front/Backend etc.) to test new features and convert manual tests into automated tests</span></p></li><li><p><span>Executing tests using diagnostic software and hardware</span></p></li><li><p><span>Additional duties as assigned</span></p></li></ul><p></p><p><b><span>Requirements:</span></b></p><ul><li><p><span>B.S. Degree in Computer Science/Electrical Engineering or higher degree</span></p></li><li><p><span>8 &#43; years’ overall experience in software test automation using progressive technologies working in a collaborative team environment</span></p></li><li><p><span>2&#43; experience managing a small team of engineers</span></p></li><li><p><span>Experience in Software Test required</span></p></li><li><p><span>Good understanding of Software Development and Test methodologies &amp; practices pertaining to a medical device regulatory environment.</span></p></li><li><p><span>Knowledge of programming/scripting languages such as Python, Java script etc.</span></p></li><li><p><span>Knowledge of App Automation tools such as Appium, Selenium and other latest tools</span></p></li><li><p><span>Excellent communication skills (ability to communicate technical concepts to a non-technical audience)</span></p></li><li><p><span>Willing to learn new technologies, accept challenges and meet product timelines</span></p></li></ul><p></p><p><b><span>Environment and Physical Activities/Requirements:</span></b></p><ul><li><p><span>You will work in an indoor <b>remote</b> environment for which no adverse conditions are expected.  This position requires the following physical activities and/or requirements:</span></p><ul><li><p><span>Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time</span></p></li><li><p><span>Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers</span></p></li><li><p><span>Communicating with others to exchange information</span></p></li><li><p><span>Adjusting, moving, carrying, lifting, pushing or pulling objects up to 20 pounds</span></p></li></ul></li></ul><p><span>#LI-DH1</span></p><p></p><p>Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.</p><p></p><p><span>Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.</span></p> Jun 6th, 2022 08:18PM Jun 6th, 2022 08:18PM

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