GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
GRAIL is using the power of high-intensity 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 and commercialize pioneering products for the early detection of cancer.
We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to alleviate the global burden of cancer.
In search of the right opportunity for you? Apply to GRAIL to be considered for future roles!
Director, Design Control
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com
As a key member of the quality team at GRAIL, the Director, Design Control will be responsible for leading and managing the Design Control efforts. The successful candidate will manage all elements of design control and documentation; risk management, development, planning, input, output, review, verification, validation, change control, specifications, SOPs, protocols, and reports. This individual will lead and/or support all quality engineering, qualification and validation activities of the product life cycle and maintain a Design History File (DHF) for the device in accordance with the approved design plan, procedures and regulations. The individual will apply “systems” thinking and knowledge of systems, reliability, risk management, standards and design V&V engineering, test method development principles, practices and implementation to support new and sustaining projects. They will establish the vision, develop procedures, and facilitate the execution of activities within GRAIL.
They will work creatively and collaboratively to engineer fit-for-purpose processes compliant with Quality regulations.
- 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/oversee the FMEAs and other risk assessment processes and documentation (as required).
- Ensure Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971:2012.
- Conduct risk assessments and create/revise risk management documents as required by Standard Operating Procedures, FDA, 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 effectiveness of the risk control measures.
- Represent the company as a Quality Assurance subject matter expert 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, utilize quality engineering methods and provide innovative solutions.
- Perform 3rd party management activities such as review of design control deliverables, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship development.
- Monitor, track/trend all KPI and periodically provide a summary report to Sr. management including participation in Management Review meetings and Material Review Board (MRB).
- Facilitate Design review activities, process capabilities, including validation in partnership with Engineering, Product/Program team, and Clinical Development team, etc.
- Provide coaching to QA, product development key stakeholders personnel on Quality Systems requirements and process improvement methodologies.
You Background Should 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.
- Exceptional 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 including Word, Excel, PowerPoint
- Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.