Quality System Manager

The Quality System Manager is responsible for developing, implementing, and sustaining the Quality Management System (QMS) across HOYA Surgical Optics entities, improving regulatory compliance, and leading the team to achieve quality management system targets.

Requirements

• At least 5 years of experience in the management of product quality or quality systems in highly regulated industry (Pharma or Medical Device)
• Have managed external audits of Notified Bodies, & preferably FDA
• Have monitored product quality in production or in the field
• Familiar with Quality System Regulation, 21 CFR 820 regulation, ISO 13485, MDSAP and MDR requirement