Quality Operations Manager - Medical Devices

• Salary and package: Available upon discussion with Projectus Consulting

The Quality Manager is responsible for ensuring medical device products are safe and compliant before market release. The role includes authority to release or block products, validate sterilization certificates, approve qualification/validation activities, and support operational quality processes.

Key Responsibilities:

• Manage document control, batch review, and product release activities.
• Ensure compliance with ISO 13485, MDR, FDA QSR, and related quality standards.
• Oversee metrology systems and management of measurement/testing equipment.
• Support non-conformance, CAPA, deviation, OOS/OOT, and change control processes.
• Approve validation, qualification, and quality documentation.
• Collaborate cross-functionally with Production, Engineering, Supply Chain, R&D, and Quality teams.
• Participate in audits as a technical quality expert.
• Lead and develop the quality/metrology team, including performance management, training, and recruitment.

Skills/Experience required:

• Master’s degree in a scientific or engineering field.
• Minimum 3 years’ experience in pharmaceutical or medical device quality operations.
• Strong knowledge of ISO 13485, ISO 14971, MDR, and FDA 21 CFR 820.
• Experience with sterilization validation, risk analysis, CAPA, and quality systems.
• Strong analytical, communication, leadership, and decision‑making skills.
• Fluent technical English and strong collaboration abilities