Quality Engineer

CH01 CHE Fresenius Medical Care (Schweiz) AG; Akdeniz Bölgesi; On-site; TRY 350,000 - 700,000; Full time

Job summary

Fresenius Medical Care Antalya plant in Turkey seeks a Quality Engineer to support manufacturing quality, CAPA, deviations, and data-driven improvements. You will work closely with Manufacturing, Process Engineering, Regulatory, and Quality teams to maintain ISO 13485 and engage in risk management and validations.

Ideal candidates have a engineering degree and at least 3 years in a regulated manufacturing environment, with strong analytical skills and experience in SPC, CAPA, and root cause

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Minimum 3 years of experience in Quality/Manufacturing/Process Engineering in a regulated environment.
• Experience with CAPA, nonconformance, root cause analyses and corrective actions.
• Knowledge of ISO 13485 and ISO 14971 preferred.
• Experience using quality tools including SPC and process capability analysis.
• Willingness to travel domestically and internationally; Antalya living preferred.

Responsibilities

• Investigate and resolve product, process, and manufacturing quality issues using structured problem-solving methodologies (8D, 5 Why, Fishbone, RCA).
• Support CAPA, nonconformance, deviation, and corrective action activities per QMS.
• Analyze data to identify trends, variation, and improvement opportunities.
• Provide technical support for customer complaints and cross-functional investigations.
• Apply SPC, process capability analysis, Pareto, trend analysis for data-driven decisions.
• Support continuous improvement, design changes, and manufacturing transfers.
• Contribute to risk management activities including FMEA and validation.
• Collaborate with Manufacturing, Process Engineering, Operations, Regulatory, Quality teams.
• Ensure compliance with ISO 13485 and ISO 14971; assist audits with documentation.

Skills

Analytical thinking

Problem-solving

Data interpretation

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Minitab

Statistical tools (SPC)

Job description

At 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 innovation At 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! We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.

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.

Creating a future worth living. For patients. Worldwide. Every day. Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.