Quality Engineer – Medical Device Manufacturing

About the role

Join Fresenius Medical Care's Antalya plant as a Quality Engineer, supporting the production of high‑quality dialysis components. You will work on a global team dedicated to improving patient outcomes through rigorous quality management.

Key responsibilities

• Investigate and resolve product, process, and manufacturing quality issues using structured problem‑solving methods such as 8D, 5 Why, and Fishbone analysis.
• Support and execute CAPA, nonconformance, deviation, and corrective action activities in compliance with the Quality Management System.
• Analyze quality and manufacturing data to identify trends, process variation, and improvement opportunities.
• Provide technical support for customer complaint investigations and collaborate with cross‑functional teams to implement effective solutions.
• Participate in continuous improvement initiatives focused on defect prevention, process robustness, and operational excellence.

Required profile

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical, Electrical & Electronics, Chemical, Industrial, Materials Science, or related discipline.
• Minimum 3 years of experience in Quality Engineering, Manufacturing Engineering, or Process Engineering within a regulated environment.
• Experience with nonconformance management, CAPA processes, root cause analysis, and corrective actions.
• Familiarity with ISO 13485 and ISO 14971 (preferred).
• Willingness to travel domestically and internationally and to relocate to Antalya if not already residing there.

Required skills

• Statistical process control (SPC), process capability analysis, Pareto and trend analysis.
• Use of statistical software (Minitab) and Microsoft Office applications.
• Lean Six Sigma Green Belt certification or equivalent experience.
• Knowledge of quality management systems and quality engineering principles.
• Experience with process validation, equipment qualification, extrusion, injection molding, automation, and assembly processes.