Quality and Compliance Manager
Core
Ensure product manufacturing aligns with quality and regulatory standards for medical devices and pharmaceuticals through process validation, risk management, and non-conformance investigation.
Role type
Senior Quality and Compliance Manager
Builds
Medical devices and pharmaceutical products
Domain
Medical Technology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory framework knowledge (FDA/Notified Body), Process validation, Risk management (PFMEA), Supplier quality management, CAPA investigation, Project management, People management, Change control, Documentation management
Preferred skills
Six Sigma, Lean, ASQ certification, Engineering background
Technologies
Microsoft Office suite
Responsibilities
Identify and assist with process validation activities; Lead risk management activities such as verification of risk mitigation implementation; Manage multiple projects in various stages of production; Inspect product including labeling and documentation for release; Provide quality engineering support in investigation of nonconformances and CAPAs; Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA)
Seniority
Senior, hands-on IC with management responsibilities
