Design Quality Manager - Medical Devices
Core
Lead the Design Quality function to ensure new and evolving medical devices meet global regulatory requirements while maintaining robust design and risk management processes.
Role type
Senior Design Quality Manager
Builds
Medical device products from early design through to commercialisation
Domain
Medical Devices / Quality Management
Required skills
Medical device design controls, risk management, ISO 13485, cGMP, FDA 21 CFR Part 820, team leadership, audit readiness
Preferred skills
FDA/ISO audit experience, cross-functional collaboration
Technologies
ISO 13485, cGMP, FDA 21 CFR Part 820
Responsibilities
Lead and mentor the Design Quality team; Provide quality leadership across design controls, risk management, and design changes; Partner with R&D on design inputs, outputs, verification, validation, and transfer; Oversee quality activities for usability, software, electrical systems, and materials; Maintain and improve the QMS for regulatory compliance.
Seniority
Senior, hands-on IC with people leadership