Quality Engineering Manager

About the role

Fresenius Medical Care's Antalya plant in Turkey produces high-quality components for dialysis therapy, including bloodlines, tubing systems and accessories, with a team of 1,600 employees. As Quality Engineering Manager you will lead and standardize Quality Engineering activities across multiple manufacturing sites producing medical devices, driving investigations, CAPA and continuous improvement.

Key responsibilities

• Lead and standardize Quality Engineering activities across manufacturing sites.
• Drive investigations of complex product and process quality issues using 8D, DMAIC, root cause analysis and FMEA.
• Provide technical leadership for CAPA, nonconformance, deviation and investigation processes.
• Analyze quality data, complaints and process trends to find systemic issues and improvement opportunities.
• Support customer complaint investigations and lead cross-functional teams (Quality, Manufacturing, Engineering, Operations, Supply Chain, Regulatory Affairs).
• Support new product introductions, design and manufacturing transfers and process changes.
• Participate in risk management, PFMEA, validation strategies and critical quality characteristic assessments.
• Ensure compliance with ISO 13485, EU MDR, FDA regulations and ISO 14971, and support internal and external audits.
• Develop and monitor quality performance metrics and report quality risks to senior management.

Required profile

• Bachelor's degree in Engineering (Mechanical, Industrial, Electronics, Manufacturing or related).
• Minimum 5 years in Manufacturing or Process Engineering in a regulated medical device environment, including at least 3 years in a leadership position.
• Excellent spoken and written English.
• Willingness to travel domestically and internationally and to live in Antalya or relocate.

Required skills

• Medical device quality systems: ISO 13485, EU MDR, FDA 21 CFR Part 820, ISO 14971, MDSAP.
• Manufacturing investigations, CAPA, root cause analysis, PFMEA, process validation and technology/design transfer.
• Minitab or similar statistical software preferred; Lean Six Sigma Green or Black Belt preferred.
• Knowledge of injection molding, extrusion, automation, assembly, bonding or sealing is an advantage.