As a key member of the quality team at GRAIL, the Associate 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, develops 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.