Product Quality Manager, Medical Devices
Core
Ensure quality and regulatory compliance for a portfolio of medical devices and combination products across the entire lifecycle.
Role type
Senior IC Product Quality Manager (Medical Devices)
Builds
Medical device and combination product portfolios
Domain
Medical Devices / Regulatory Compliance
Required skills
cGMP, MDR (EU) 2017/745, 21 CFR Part 820, GDP, ISO13485, ICH, sterile product knowledge, Design Control, technical transfer, process validation, risk assessment, CAPA, external site oversight
Preferred skills
Lean Six Sigma, global lifecycle management, external partner oversight
Technologies
ASQ Certified Quality Auditor, Lean Six Sigma
Responsibilities
Drive quality oversight for assigned products and projects; Contribute to product development, technical transfers, and process validation; Review and assess quality documentation including Design Control and risk assessments; Support quality oversight of external manufacturing sites and partners; Enable inspection readiness; Engage in quality risk assessments, investigations, and CAPAs; Provide quality input and recommendations for governance decisions
Seniority
Senior, hands-on IC