Quality Engineer , Device Quality Operations

Quality Engineer 2, Device Quality Operations #4376

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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.

GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. We use next‑generation sequencing, 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 Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom.

This position is a key individual contributor in the Quality Operations organization, responsible for executing, maintaining, supporting, and improving GRAIL’s quality management system (QMS) for in‑vitro diagnostic medical devices. The role requires regular on‑site presence (5 days a week) and collaborates with multiple departments including Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain, Manufacturing, and Research & Development.

• Support medical device Quality Engineering operations through expert interpretation, establishment, and execution of quality engineering concepts and principles in accordance with GRAIL’s QMS and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and related regulations and standards.
• Use proactive, creative problem‑solving to contribute to development of concepts and principles to achieve goals and objectives.
• Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
• Analyze complex problems requiring in‑depth evaluation and assessment of intangible variables.
• Exercise excellent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Act independently to determine methods and procedures to successfully complete assignments.
• Structure day‑to‑day work autonomously, effectively communicating status and issues with management.
• Identify and evaluate deficiencies and improvement opportunities, working cross‑functionally to resolve and improve existing processes.
• Support qualification & validation activities (IQ/OQ/PQ/TMV).
• Support DHR review process.
• Support NCR, DAR & CAPA process.
• Support change‑management workflows and acceptance activities including incoming and finished product release.
• Support Quality Management Review (QMR), Quality Indices metrics generation and review, audits, and on‑market Design History File and Risk Management File updates.
• Support audits and inspections as needed.
• Support other project teams (including clinical laboratory) as determined by management.

• Bachelor’s degree in science, engineering, or another technical area.
• Minimum of 5 years of experience working within a medical device, pharmaceutical, or biotech quality management system.
• Experience with in‑vitro diagnostic medical device regulations and standards including ISO 13485:2016, 21 CFR 820, IVDR, and other applicable industry requirements.
• Strong written and verbal communication skills.
• Ability to comprehend and interpret technical information.

Compensation
:
Expected full‑time annual base pay scale is $82,000 – $96,000 for NC. Actual base pay will consider skills, experience, and location.

Benefits include a competitive package: flexible time off, 401(k) with company match, medical, dental, and vision insurance, and mindfulness offerings.

GRAIL is an equal employment opportunity employer and is committed to building a workplace where every individual can thrive. We provide equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class protected by applicable laws. GRAIL maintains a drug‑free workplace.

GRAIL will consider all qualified job seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations for individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position.