Quality Engineering Specialist

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 from Science or Engineering Departments (Biology/Chemistry Engineering),
• Minimum 2 years of quality management system experience in production plants,
• Proficient in MS office and relevant engineering programs,
• Excellent command of English, both oral and written,
• Quality management system standard experience (EN ISO9001, EN ISO13485),
• Preferably, experience in the field of medical device quality management system and medical device regulation,
• Preferably having knowledge and experience in statistics and reporting,
• Preferably experience in medical production quality processes for injection, extrusion, or automation (pFMEA, validation, process changes etc.),
• Strong communication and negotiation skills,
• Dynamic, disciplined and focused to responsibilities,
• Working according to company core values and compliance rules,
• Having problem skills with analytic approach,
• Living in Antalya or willing to relocate.

KEY RESPONSIBILITIES

•        Ensure the execution of process/test method validation processes in alignment with applicable regulations, standards, and GMS procedures.
•        Lead and manage the calibration processes of equipment within the Quality Department, including internal and external calibrations. Monitor calibration KPIs and define or revise calibration periods as required.
•        Support the validation and oversight of e-beam sterilization of finished products performed by subcontractors. Review all relevant documentation provided by e-beam service partners.
•        Ensure effective and timely execution and monitoring of pFMEA studies within assigned areas, in accordance with valid QMS risk management processes.
•        Oversee testing and validation activities, including preparation, execution, and reporting of validation protocols, ensuring compliance with quality standards.
•        Support the timely implementation, monitoring, and closure of NC/CAPA activities in Qtrak related to test methods and test equipment calibrations, as per QMS procedures.
•        Contribute to the definition, execution, and continuous improvement of Quality System (QS)–related projects.
•        Provide recommendations for process improvements, participating in planning and implementing changes to manufacturing or process control requirements and related site documentation.
•        Review and update local procedures, work instructions, and forms related to process/test method validation, calibration, and e-beam sterilization as necessary.
•        Support management through the compilation, evaluation, and reporting of key product quality metrics and trends.

OUR OFFER FOR YOU

• Salaries paid in Euro currency
• 13th-month salary payment
• Relocation assistance for candidates coming from outside the city
• Birthday leave
• Private health insurance