Quality Manager
Core
Lead and develop the Quality team to maintain and improve the Quality Management System (QMS) for ophthalmic diagnostic and surgical lenses, ensuring compliance with global medical device regulations.
Role type
Senior Quality Manager (Medical Devices)
Builds
Compliant medical device manufacturing processes and quality systems
Domain
Medical Devices / Ophthalmic Lenses / Regulated Manufacturing
Required skills
Quality Management System (QMS) leadership, ISO 13485 compliance, FDA 21 CFR §820 regulations, CAPA management, root cause analysis, risk management (FMEA), audit leadership, data analysis, cross-functional influence
Preferred skills
Advanced degree in Engineering, experience in regulated manufacturing environment
Technologies
ISO 13485, FDA 21 CFR §820, FMEA
Responsibilities
Lead and develop the Quality team, maintain and improve the QMS, serve as Management Representative for ISO and certification audits, analyze quality data and trends to identify improvement opportunities
Seniority
Senior, hands-on IC