Quality and Compliance Manager
Core
Ensure ongoing product manufacturing aligns with established quality and regulatory standards for medical devices and combination products.
Role type
Senior Quality and Compliance Manager (Medical Device/Pharma)
Builds
Medical devices and combination products
Domain
Medical Technology / Regulatory Compliance
Required skills
Regulatory framework knowledge (FDA/Notified Body), Risk management (PFMEA), Supplier quality management, CAPA investigation, Process validation, Project management, People management
Preferred skills
Six-sigma, Lean, ASQ certification
Technologies
Microsoft Office suite
Responsibilities
Identify and assist with process validation activities; Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA); Inspect product including labeling and documentation for release of finished goods; Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs; Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.)
Seniority
Senior, hands-on IC with people management