Quality Engineer

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

## Quality EngineerApply: Onsite: Antalya, Turkey: Full time: Posted Today: End Date: October 31, 2026 (30+ days left to apply): R0269450At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work:* We Care for our patients, each other, and our communities* We Connect across teams and borders to deliver excellence together* We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovationAt our Antalya plant in Turkey, we focus on the production of high-quality components used in dialysis therapy, including bloodlines, tubing systems, and accessories. With a dedicated team of 1,600 employees, our facility utilizes advanced technologies such as bloodline assembly, automated sub-assembly, extrusion, injection molding, and ETO sterilization. This site plays a vital role in Fresenius Medical Care’s commitment to enhancing patient care worldwide. Join our passionate team and be part of this global impact!**REQUIRED QUALIFICATIONS*** Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical & Electronics Engineering, Chemical Engineering, Industrial Engineering, Materials Science, or a related technical discipline,* Minimum 3 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or a related role within a regulated manufacturing environment. (Medical device industry experience is preferred),* Experience with nonconformance management, CAPA processes, root cause analysis, investigations, and corrective actions,* Knowledge of Quality Management Systems and quality engineering principles. Familiarity with ISO 13485 and ISO 14971 is preferred,* Experience using quality and statistical tools, including SPC, process capability analysis, Pareto analysis, and trend analysis,* Strong analytical, problem-solving, and data interpretation skills,* Excellent communication and cross-functional collaboration abilities,* Lean Six Sigma Green Belt certification or equivalent experience is considered an asset,* Experience with process validation, equipment qualification, manufacturing transfers, extrusion, injection molding, automation, or assembly processes is preferred,* Proficiency in Microsoft Office applications and statistical software (Minitab preferred).* Willingness to travel domestically and internationally as required,* Living in Antalya or willing to relocate.**KEY RESPONSIBILITIES*** Investigate and resolve product, process, and manufacturing quality issues using structured problem-solving methodologies such as 8D, 5 Why, Fishbone, and Root Cause 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, 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 such as SPC, process capability analysis, Pareto analysis, trend analysis, and measurement system analysis to support data-driven decision-making.* Participate in continuous improvement initiatives focused on defect prevention, process robustness, variation reduction, and operational excellence.* 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 closely with Manufacturing, Process Engineering, Operations, Supply Chain, Regulatory Affairs, and Quality teams to improve product and process performance.* Ensure compliance with applicable quality standards and regulatory requirements, including ISO 13485 and ISO 14971.* Support internal and external audits by providing technical documentation, investigation records, and quality evidence.* Promote best practices and knowledge sharing across manufacturing sites to support standardized quality engineering processes.