Quality Engineer

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

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!

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.