Quality Engineer - Medical Devices | CAPA & Process

CH01 CHE Fresenius Medical Care (Schweiz) AG; Muratpaşa; On-site; TRY 350,000 - 520,000; Full time

Job summary

Fresenius Medical Care in Antalya, Turkey is seeking a Quality Engineer to join our manufacturing team. The role emphasizes resolving quality issues, leading CAPA activities, and applying SPC and other quality tools to drive continuous improvement in dialysis component production.

The ideal candidate has a technical engineering degree, 3+ years in a regulated environment, and strong collaboration across functions. Onsite role with opportunity for domestic/international travel as needed.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 3 years in Quality/Manufacturing Engineering in a regulated environment.
• Experience with nonconformance management, CAPA, root cause analysis, investigations, and corrective actions.

Responsibilities

• Investigate and resolve product, process, and manufacturing quality issues using structured problem-solving methods (8D, 5 Why, Fishbone).
• Support and execute CAPA, nonconformance, deviation, and corrective action activities in line with QMS.
• Analyze quality and manufacturing data to identify trends and opportunities for improvement.
• Provide technical support for customer complaint investigations and collaborate with cross-functional teams to implement solutions.
• Apply statistical quality tools (SPC, capability analysis, Pareto, trend analysis) to data-driven decisions.
• Participate in continuous improvement initiatives focused on defect prevention and robustness.
• Support new product introductions, process changes, and manufacturing transfers.
• Contribute to risk management activities including FMEA and validation, and ensure regulatory compliance.

Skills

Nonconformance management

CAPA processes

Root cause analysis

Investigations

Quality data interpretation

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab

Microsoft Office

Job description

Fresenius Medical Care in Antalya, Turkey is seeking a Quality Engineer to join our manufacturing team. The role emphasizes resolving quality issues, leading CAPA activities, and applying SPC and other quality tools to drive continuous improvement in dialysis component production.

The ideal candidate has a technical engineering degree, 3+ years in a regulated environment, and strong collaboration across functions. Onsite role with opportunity for domestic/international travel as needed.