Quality Manager – Medical Devices

About the role

The Quality Manager will ensure that medical device products released to the market are safe, compliant and meet all regulatory requirements. Reporting to senior management, you will have authority to release or block products and will support the entire quality lifecycle.

Key responsibilities

• Manage document control, batch review and product release activities.
• Maintain compliance with ISO 13485, MDR, FDA QSR (21 CFR 820) and related standards.
• Oversee metrology systems and the calibration/maintenance of measurement and testing equipment.
• Drive non‑conformance, CAPA, deviation, OOS/OOT and change‑control processes.
• Approve validation, qualification and all quality documentation.
• Collaborate with Production, Engineering, Supply Chain, R&D and Quality teams.
• Act as technical quality expert during internal and external audits.
• Lead, coach and recruit the quality/metrology team, handling performance management and training.

Required profile

• Master’s degree in a scientific or engineering discipline.
• Minimum three years of experience in pharmaceutical or medical‑device quality operations.
• Strong knowledge of ISO 13485, ISO 14971, MDR and FDA 21 CFR 820.
• Proven experience with sterilization validation, risk analysis, CAPA and quality‑system management.
• Fluent technical English and excellent collaboration skills.

Required skills

• ISO 13485
• ISO 14971
• MDR
• FDA 21 CFR 820
• Sterilization validation
• Risk analysis
• CAPA
• Quality systems
• Metrology and equipment calibration

What we offer

• Permanent contract.
• Salary and benefits discussed with Projectus Consulting.