Quality Engineer, Medical Devices – Global Impact

freseniusmedicalcare; Muratpaşa; On-site; TRY 600,000 - 800,000; Full time

Job summary

Fresenius Medical Care Antalya plant is seeking a Quality Engineer to join our manufacturing team focused on dialysis components. You will apply quality tools, support CAPA, nonconformance, and process validation to ensure product quality and regulatory compliance.

Ideal candidates have a bachelor’s in engineering and at least 3 years in a regulated manufacturing environment, with strong analytical skills and cross-functional collaboration. Willingness to travel and relocate to Antalya as needed.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Minimum 3 years in quality/manufacturing engineering in a regulated environment.
• Experience with nonconformance management, CAPA, and root cause investigations.
• Knowledge of ISO 13485 and ISO 14971 preferred.
• Experience with quality tools: SPC, Pareto, trend analysis; strong data interpretation.

Responsibilities

• Investigate and resolve product, process, and manufacturing quality issues using structured problem-solving methods (8D, 5 Why, Fishbone, RCA).
• Support CAPA, nonconformance, deviation, and corrective action activities per QMS.
• Analyze quality/manufacturing data to identify trends and opportunities for improvement.
• Provide technical support for customer complaint investigations and cross-functional collaboration.
• Apply statistical quality tools to support data-driven decisions and risk management.
• Participate in continuous improvement and technology transfer initiatives.
• Ensure compliance with ISO 13485, ISO 14971 and regulatory requirements.
• Assist audits with documentation and evidence as needed.

Skills

Quality engineering

Statistical analysis

CAPA

Root cause analysis

ISO 13485 knowledge

Minitab proficiency

Process validation

Cross-functional collaboration

Lean Six Sigma

Data interpretation

Education

Bachelor's degree in Engineering

Tools

Minitab

Statistical software

Job description

Fresenius Medical Care Antalya plant is seeking a Quality Engineer to join our manufacturing team focused on dialysis components. You will apply quality tools, support CAPA, nonconformance, and process validation to ensure product quality and regulatory compliance.

Ideal candidates have a bachelor’s in engineering and at least 3 years in a regulated manufacturing environment, with strong analytical skills and cross-functional collaboration. Willingness to travel and relocate to Antalya as needed.