Design Quality Engineer III

Purpose The Senior Design Quality Engineer serves as the quality representative and subject matter expert for new product development and lifecycle management activities. This role provides leadership in the application of Design Controls, Risk Management, Verification & Validation, usability engineering, transfer to manufacturing, and regulatory compliance activities for medical devices. The Senior Design Quality Engineer independently leads complex quality engineering projects, provides strategic guidance to cross-functional teams, mentors junior engineers, and partners with Regulatory Affairs, R&D, Clinical, Manufacturing, Supply Chain, and Operations to ensure products are developed and maintained in accordance with applicable global regulations and quality system requirements. **This is an on-site role in Memphis, TN.** Key Duties and Responsibilities Serve as Design Quality lead for product development projects. Provide quality oversight throughout the design control process. Lead risk management activities in accordance with ISO 14971. Review and approve DHF documentation. Support design reviews and ensure compliance with FDA, ISO 13485, EU MDR, and other applicable regulations. Provide quality leadership for verification and validation activities. Support design transfer and manufacturing readiness activities. Act as quality SME for product development teams. Lead investigation of complex product complaints, field issues, and quality events related to commercialized products. Support complaint trending, post-market surveillance, and product performance monitoring. Lead or support NCs/CAPAs associated with released products. Evaluate and implement design changes, supplier changes, manufacturing changes, and risk management updates impacting released products. Partner with Operations, Regulatory Affairs, and Supply Chain to resolve product quality issues. Support assessment of field actions, recalls, and regulatory reporting activities as applicable. Participate in lifecycle risk assessments and product improvement initiatives. Internal quality procedures Support global regulatory submissions and associated quality documentation. Participate in internal, supplier, customer, and regulatory audits. Support inspection readiness activities. Ensure quality records comply with regulatory and internal requirements. Drive continuous improvement initiatives within the Quality Management System. Mentor and provide technical guidance to Quality Engineers and cross-functional partners. Lead complex quality engineering projects with minimal supervision. Develop and improve quality engineering procedures, templates, and best practices. Serve as a technical escalation point for quality and compliance issues. Influence strategic quality decisions through risk-based decision making. MINIMUM REQUIREMENTS B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 5+ years of medical device…