Quality Engineering Manager

About the role

Fresenius Medical Care seeks a Quality Engineering Manager to lead and standardize quality engineering activities across multiple manufacturing sites producing dialysis‑related medical devices. The role is based at the Antalya plant and involves driving investigations, CAPA, and continuous improvement initiatives.

Key responsibilities

• Lead investigations of complex product and process quality issues using structured problem‑solving methods (8D, DMAIC, FMEA, statistical analysis).
• Provide technical leadership for CAPA, non‑conformance, deviation and investigation processes, ensuring sustainable corrective actions.
• Analyze quality data, complaints and manufacturing trends to identify systemic issues and improvement opportunities.
• Support new product introductions, design transfers and manufacturing transfers while managing quality risks.
• Participate in risk management activities, including PFMEA, validation strategies and critical quality characteristic assessments.
• Drive continuous improvement focused on defect prevention, yield improvement and operational excellence.

Required profile

• Bachelor’s degree in Mechanical, Industrial, Electronics, Manufacturing or related engineering field.
• Minimum 5 years of manufacturing or process engineering experience in a regulated medical‑device environment, with at least 3 years in a leadership role.
• Excellent command of English, both oral and written.
• Willingness to travel domestically and internationally and to relocate to Antalya if not already residing there.

Required skills

• Strong knowledge of ISO 13485, EU MDR, FDA 21 CFR Part 820, ISO 14971 and MDSAP.
• Hands‑on experience with PFMEA, process validation, design transfer projects and manufacturing risk management.
• Proficiency with statistical analysis tools such as Minitab.
• Lean Six Sigma Green Belt or Black Belt certification (preferred).
• Familiarity with injection molding, extrusion, automation, assembly, bonding or sealing processes.