Design and Development Quality Manager
Core
Lead the Design Quality team to provide strategic quality oversight across product design and development for medical devices.
Role type
Senior Design and Development Quality Manager
Builds
Medical device products (wound care, regenerative healing)
Domain
Medical device manufacturing / Regulatory Quality
Required skills
Design controls, Risk management, Quality planning, cGMP, ISO 13485, FDA 21 CFR Part 820, Team leadership, Audit readiness
Preferred skills
ISO 9001/13485 auditor certification, Knowledge of 21 CFR Part 11 and GAMP, Usability engineering, Software/electrical/materials knowledge
Technologies
ISO 13485, ISO 14971, FDA 21 CFR Part 820, 21 CFR Part 11, GAMP
Responsibilities
Lead and coach the Design Quality team, Oversee Design History Files (DHF) and risk management, Collaborate on product development and usability, Maintain compliant quality systems for design and labelling, Resolve complex technical and compliance issues, Support audit/inspection readiness
Seniority
Senior, hands-on IC with leadership scope
