Project Quality Manager (m/w/d)
Core
Coordinate quality activities across the entire product development process and support international production sites in achieving successful series production.
Role type
Senior Project Quality Manager
Builds
Regulated medical devices, pharmaceuticals, or healthcare products
Domain
Healthcare / Medical Devices / Pharma
Required skills
Quality management, Project management, Risk management (FMEA), Qualification and validation processes, Regulatory compliance, Supplier quality management, Design verification, Validation master planning
Preferred skills
Experience in regulated industries (Pharma, Medical Devices, Healthcare), Stakeholder management, International team collaboration
Technologies
FMEA, PQ, PV, Design Verification
Responsibilities
Coordinate quality activities in development and transfer projects, Plan and moderate risk analyses and FMEAs, Serve as central contact for customer quality inquiries, Develop risk-based validation strategies and master plans, Plan and coordinate qualification and validation activities, Ensure quality requirements for purchased parts, Develop regulatory strategies for target markets, Support international production sites during transfer phase