Senior Director, Design Control & Quality Engineering

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

As a key member of the quality team at GRAIL, the Sr Director, Design Control & Quality Engineering will be responsible for leading Design Control processes and Quality Engineering efforts for product lifecycle management. The successful candidate will manage all elements of design control and product Quality Engineering documentation; risk management, development, design planning, design inputs & outputs, review, verification, validation, change control, specifications, SOPs, protocols, and reports.
You will:

• Collaborate with functional leads to design and build Quality System processes to work with GRAIL’s existing systems and product pipelines.
• Design, develop, approve, and implement Design Control Quality Systems SOPs, forms, reports, protocols, and documents associated with design control and Validations processes.
• Approve changes to process and new design activities.
• Provide QA support for Test method assay Product development from feasibility through transfer into commercialization.
• Perform and review/approve design control and risk management activities.
• Work closely with research and development organizations to ensure potential product issues are identified and addressed in the design.
• Work effectively and influence multiple functions (R&D, Operations, Product/Program, Regulatory, Supply Chain, Medical, etc.) to ensure design control expectations are met.
• Develop/lead all aspects of the FMEAs and other risk assessment processes and documentation.
• Ensure Quality Risk Management Files are in alignment with 21CFR Part 820.30 design control, Product Realization requirements under ISO 13485 and risk management requirements of ISO 14971.
• Conduct risk assessments and Create/revise risk management documents as required by Standard Operating Procedures and other medical device regulations.
• Lead assessment of hazard analyses, design risk assessments, use of risk assessments, system risk assessments, and process risk assessments.
• Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the efficiency of the risk control measures.
• Represent the company as a Quality Assurance SME during internal and external regulatory inspections.
• Ensure design control documentation and requirements are met.
• Anticipate and manage project risks and issues, and provide specific mitigation and corrective action strategies.
• Work on complex technical problems, apply quality engineering methods and provide innovative solutions.
• Perform 3rd party management activities such as review of design control work, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship development.
• Monitor, track/trend all critical metric and periodically provide a summary report to Sr. management including participation in Quality Management Review meetings and Product Lifecycle meetings.
• Facilitate Design review activities, process capabilities, including validation in partnership with Engineering, Product/Program team, and Clinical Development team, etc.
• Mentor QA, product development key collaborators, on Quality Systems requirements and process improvement methodologies.

Your background and qualifications will include:

• Minimum of a Bachelor of Science Degree in Engineering or scientific field with at least 10+ years of validation experience in the medical device or combination products industry.
• ASQ, CQE, CQA, black belt or other equivalent certification is preferred.
• At least 5 years of direct managerial responsibility leading all aspects of Design Control and Validation for Medical Devices
• Extensive experience and understanding of design, development, verification and validation processes.
• Outstanding working knowledge and understanding of Device and Combination products regulations (21CFR 820 and ISO 13485), Risk Assessment (ISO 14971, ICHQ 9), ASTM standards and other ICH guidance.
• Proven experience in managing FMEAs, Lean/Six Sigma projects, black belt, process validation, process capability, statistical analysis and application of statistical methods (JMP, Minitab).
• Excellent verbal, written, communication and proficient computer skills, specifically with statistical software and Microsoft Office Suite.
• Must be able to work in a biohazard environment and align with safety policies and standards outlined in the Safety Manual.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.