Quality Engineer – Medical Devices with Data-Driven Improvement

Fresenius Medical Care; Muratpaşa; Sur place; TRY 300 000 - 520 000; Plein temps

Résumé du poste

Fresenius Medical Care seeks a Quality Engineer at our Antalya, Turkey site to lead investigations and CAPA activities for medical device manufacturing. You will analyze data, apply SPC and RCA methods, and collaborate with cross-functional teams to drive process improvements.

The role requires a technical degree and 3+ years in regulated manufacturing, with travel as needed and relocation to Antalya if required.

Qualifications

• Bachelor's degree in a technical discipline and 3+ years in a regulated manufacturing environment.
• Experience with nonconformance management, CAPA, root cause analysis, investigations, and corrective actions.
• Knowledge of Quality Management Systems and ISO 13485/14971 preferred.
• Experience using quality and statistical tools (SPC, process capability, Pareto, trend analysis).
• Strong analytical, problem-solving, and data interpretation skills.
• Excellent communication and cross-functional collaboration; Lean Six Sigma Green Belt is a plus.
• Willingness to travel domestically and internationally; living in Antalya or relocation.

Responsabilités

• Investigate and resolve product, process, and manufacturing quality issues using structured problem-solving methodologies (8D, 5 Why, Fishbone, RCA).
• Support and execute CAPA, nonconformance, deviation, and corrective action activities in compliance with the QMS.
• Analyze quality and manufacturing data to identify trends, process variation, recurring issues, and opportunities for improvement.
• Provide technical support for customer complaint investigations and collaborate with cross-functional teams to determine root causes and implement effective solutions.
• Apply statistical quality tools (SPC, process capability, Pareto, trend analysis, MSA) to support data-driven decisions.
• Participate in continuous improvement initiatives focused on defect prevention and process robustness.
• Support new product introductions, design changes, process improvements, technology transfers, and manufacturing transfer projects.
• Contribute to risk management activities, including FMEA, process controls, validation activities, and quality planning.
• Collaborate with Manufacturing, Process Engineering, Operations, Supply Chain, Regulatory Affairs, and Quality teams to improve product and process performance.
• Ensure compliance with ISO 13485 and ISO 14971; support audits with documentation.
• Promote best practices across manufacturing sites to support standardized quality engineering processes.

Connaissances

Quality engineering

CAPA processes

Root cause analysis

Data interpretation

SPC

Minitab

Cross-functional collaboration

Travel willingness

Formation

Bachelor's degree in engineering or related technical discipline

Outils

Minitab

Excel

Description du poste

Fresenius Medical Care seeks a Quality Engineer at our Antalya, Turkey site to lead investigations and CAPA activities for medical device manufacturing. You will analyze data, apply SPC and RCA methods, and collaborate with cross-functional teams to drive process improvements.

The role requires a technical degree and 3+ years in regulated manufacturing, with travel as needed and relocation to Antalya if required.