Staff Quality Engineer, CAPA Program #4693

Confirmed live in the last 24 hours

GRAIL

Durham, NC

On-site

Posted March 10, 2026

Job Description

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.

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