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Staff Quality Engineer, CAPA Program #4693
GRAILUnited Statesfull_timeVerifiedPosted 10 Mar 2026
💰 $156,000/yr($118,000/yr – $156,000/yr)
About the role
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com
Reporting to the Senior Director, Quality Strategy & Operational Excellence, the Staff Quality Engineer is responsible for leading, executing, maintaining, and improving the Corrective and Preventive Action (CAPA) program in accordance with ISO 13485:2016 and 21 CFR Part 820, Quality Management System Regulation. This role additionally supports the Nonconformance (NCR) program, Quality Management Review (QMR), clinical laboratory Quality Monitoring and Improvement (QMI), Quality Indices (QI), Change Control, Quality Planning, clinical laboratory licensure/certification, internal and external audits, and other activities as assigned. This person will work cross-functionally to ensure alignment and implementation of QMS programs while adhering to strict project and program timelines and deliverables. The person in this role consistently applies critical thinking skills and good judgment to solve complex problems, effectively communicating status and recommendations to management. This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com
Reporting to the Senior Director, Quality Strategy & Operational Excellence, the Staff Quality Engineer is responsible for leading, executing, maintaining, and improving the Corrective and Preventive Action (CAPA) program in accordance with ISO 13485:2016 and 21 CFR Part 820, Quality Management System Regulation. This role additionally supports the Nonconformance (NCR) program, Quality Management Review (QMR), clinical laboratory Quality Monitoring and Improvement (QMI), Quality Indices (QI), Change Control, Quality Planning, clinical laboratory licensure/certification, internal and external audits, and other activities as assigned. This person will work cross-functionally to ensure alignment and implementation of QMS programs while adhering to strict project and program timelines and deliverables. The person in this role consistently applies critical thinking skills and good judgment to solve complex problems, effectively communicating status and recommendations to management. This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.
Responsibilities:
- Lead GRAIL’s CAPA program within the Quality Management System (QMS), including planning and running CAPA Review Board meetings, overseeing program and individual CAPA activities to ensure on-time and compliant execution, and delivering effective training to CAPA Owners and stakeholders.
- Maintain and improve the CAPA program in compliance with GRAIL’s Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards.
- Support generation and analysis of Quality Indices reports (quality metrics) as part of Measurement, Analysis, and Improvement activities, rolling up into medical device QMR and clinical laboratory QMI meetings.
- Facilitate quality planning activities including optimizing planning tools, workflows, and documentation, and obtaining and communicating status, escalating effectively as needed to obtain executive awareness and support.
- Respond to process and software system-related inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote compliant and standard process execution.
- Lead software system configuration maintenance and improvements, including testing and validation, updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience.
- Cultivate positive relationships with cross-functional partners, leadership team members, and personnel executing and supporting these processes.
- Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Proactively resolve a wide range of issues in creative and compliant ways. Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
- Exercise good judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Act independently with regular oversight to determine methods and procedures to successfully complete assignments.
- Structure day-to-day work autonomously, effectively communicating status and issues with management.
- Participate in preparation for and execution of internal and external audits and inspections. Support timely and compliant responses to
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