Senior Supplier Quality Engineer

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.

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This position is a key individual contributor within the Quality organization, responsible for executing, maintaining, and improving elements of GRAIL’s quality management system (QMS). The primary focus is on supporting GRAIL’s Supplier Quality System for medical device processes. This position interacts with suppliers as well as with departments across the organization, including but not limited to Quality, Procurement, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Quality Assurance, Supply Chain, Manufacturing, and Research & Development.

The person in this role consistently applies critical thinking and sound judgment to solve broad, complex problems, effectively cascading functional strategy and decisions across teams, and communicating status and recommendations to senior 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.

• Primary responsibilities include leading supplier qualification activities, supporting Quality Management Review (QMR), generating Quality Indices metrics, evolving standards watch and management, managing the Quality Planning process, and supporting efforts to obtain and maintain licenses, accreditations, and certifications.
• Represents Quality during audits and inspections, as well as on various project teams as determined by management.
• Support Quality through interpretation, establishment, and execution of quality engineering concepts and principles, in accordance with GRAIL’s quality management system and regulatory requirements, including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards.
• Independently manage activities relating to supplier qualification, performance, audit, changes, and corrective actions.
• Use proactive, creative problem-solving to contribute to the development of concepts and principles to achieve goals and objectives, including collaboration with suppliers and internal departments to implement robust Supplier Quality Agreements.
• Demonstrate technical proficiency, creativity, teamwork, collaboration, and independent thought.
• Exercise good judgment within broadly defined practices and policies when selecting methods, techniques, and evaluation criteria for 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 to management.
• Identify and evaluate deficiencies and improvement opportunities, working cross-functionally to resolve and improve existing processes.
• Demonstrate increasing technical proficiency by solving progressively complex problems and operating with greater independence.
• Conduct supplier audits to ensure ongoing compliance with ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH,…