About the Role We’re looking for a Quality Manager to join our team on a temporary 12-month assignment. In this role, you’ll ensure our Quality Management System (QMS) meets ISO 13485, EU MDR, and FDA standards, while driving compliance, audits, and continuous improvement across operations. Key Responsibilities
Lead and maintain the QMS in line with ISO 13485 and FDA 21 CFR Part 820
Manage internal audits, risk management, and complaint investigations
Support product registrations and technical documentation
Supervise and develop a small QA team
Coordinate external audits and ensure compliance with quality standards
Collaborate cross-functionally to resolve quality issues and drive improvements
Experience & Skills
Bachelor’s degree in Science, Engineering, or related field (HBO level preferred)
Proven experience in medical device manufacturing or similar regulated industry
Strong knowledge of ISO 13485, EU MDR, and FDA 21 CFR Part 820
Experience in product/process validation; sterilization knowledge is a plus
Excellent English communication skills (German a plus)