In this role, the individual is primarily responsible for performing Quality Management System activities in support of the development and manufacture of tissue and polymer based medical devices and components based on regulatory requirements and proven quality control and good manufacturing practice (GMP) concepts. The individual will plan, prepare, and execute internal and supplier quality audits and communicate, track, and analyze quality audit results and their corrective and preventive action and act as Chair of the Corrective Action Board, managing investigations and timelines for completing on-time CAPA activities. Individual will provide expertise in the areas of compliance, quality assurance, design controls, risk management, statistical techniques, and regulatory compliance and submissions for medical devices and components and work directly with project engineering and manufacturing personnel in the development and execution of equipment qualification, process validation, Master Validation Plan documentation, and process improvement efforts by developing and updating procedures and work instructions. Plan and manage project and design services work in accordance with defined deliverable targets including: new product introductions, development and approval of new product documentation, qualification of new suppliers/requalification of existing suppliers, dFMEA , risk management activities. Provide expertise for new product introduction/product development/process changes with respect to: acceptance criteria development, test method development/validation activities, product/process validation protocol development and execution (IQ, OQ, PQ), pFMEA , risk management activities.