Base: not specified; bonus/equity: not specified; ...
Hybrid
Global quality strategy
Regulatory compliance
Cross-functional leadership
Fibrogen is seeking a Head of Quality for Device and Combination Products to lead global quality strategy and ensure compliance with regulatory standards. The ideal candidate will have extensive experience in medical device quality, strong leadership skills, and a strategic mindset
Matching Summary
Match Score: 85
Fibrogen is seeking a Head of Quality for Device and Combination Products to lead global quality strategy and ensure compliance with regulatory standards. The ideal candidate will have extensive experience in medical device quality, strong leadership skills, and a strategic mindset.
Salary
Base: Not specified; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Global quality strategy
Regulatory compliance
Cross-functional leadership
Device and combination product expertise
Quality management system (QMS) oversight
Health Authority audits
CMO supply chain coordination
Nice-to-have
Strategic mindset
Innovative problem-solving
Collaborative environment
Continuous improvement focus
Key Requirements
BS in Chemical Engineering, Mechanical Engineering, or relevant field
12+ years of medical device quality experience
5+ years in clinical quality operations or device quality
Knowledge of 21 CFR 820, ISO 13485, ISO 14971, EU MDR