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 Design and Product Engineering team at GRAIL, the Senior Quality Engineer, Risk Management (contract) plays an integral role in supporting quality activities related to Design Control and product lifecycle management efforts in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulations (QSRs), ISO 13485, CLIA/CAP, and applicable state requirements. The successful candidate will work with product development teams to ensure that appropriate risk management and control measures are applied during development and transfer of Grail products. The individual will apply “systems” thinking and knowledge of medical device products, molecular diagnostics, applicable industry or regulatory standards, design verification and validation, manufacturing transfer, test method development principles, and risk management to support new and sustaining projects.
- Provide QA support for product development from feasibility through transfer into commercialization for risk management activities.
- Support documentation appropriate for regulatory submissions.
- Ensure design control and risk management documentation and requirements are met.
- 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.
- Facilitate 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.
- Work on complex technical problems, utilize quality engineering methods and provide innovative solutions.
- Ensure compliance to Design Control Quality Systems SOPs, forms, reports, protocols, and documents associated with design controls processes.
Your background and experience will include:
- Minimum of a Bachelor of Science Degree in a related scientific or engineering field.
- 5+ years Quality and/or Development experience in product development, product transfer, verification, and validation under Design Controls in the life sciences industry, preferably in a FDA regulated medical device/IVD environment.
- Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, ISO 14971, CAP/CLIA, and other applicable quality and regulatory standards).
- Extensive experience and understanding of design, development, verification and validation processes.
- Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment.
- Effective verbal and written communication skills and the ability to share and receive information from all levels of the organization throughout various departments.
- Travel may be required up to 15% of the time, both domestically and internationally.
- Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.