Quality Control Senior Project Engineer / Specialist

Nova Med GMBH

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 (preferred Biomedical, Chemistry, Material and Metallurgical or Mechanical Engineering,),
• Minimum 5 years of quality management system experience in Automotive / Foods&Drugs / Medical Products / Electronics production plants,
• Ability to build team environment and create collaboration between the team,
• Ability to take initiatives, guide people and evaluate risks,
• Proficient in MS office and relevant engineering programs, (Minitab and Power BI is an asset)
• Excellent command of English, both oral and written,
• Quality management system standard experience (EN ISO9001, EN ISO13485),
• Excellent interpersonal and communication skills, experience in interact effectively with all levels of management,
• Experience in the field of medical device quality management system and medical device regulation,
• Preferably experience in medical production quality processes (Microbiology/Chemistry, Quality Control for Final Inspection, pFMEA, validation etc.),
• Preferably having knowledge and experience in statistics and reporting,
• 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

• Management of the team consisting of experienced quality engineers, specialists and analyst.
• Be responsible for refining and improving lines to increase efficiency of quality tests (frequency control, historical data analysis to be revised samplings etc.)
• Be responsible for finding, eliminating faults and increase test efficiencies,

• Monitor Quality Test KPIs and define or revise frequency/sampling as required.
• Contribute to the definition, execution, and continuous improvement of Quality System (QS)–related projects.
• Support management through the compilation, evaluation, and reporting of key product quality metrics and trends.
• 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.
• Support the timely implementation, monitoring, and closure of NC/CAPA activities in Qtrak related to all quality control test and test equipment, as per QMS procedures.
• Proficiency in using and applying engineering and project management methodologies, tools & techniques 
• Provide recommendations for process improvements, participating in planning and implementing changes to manufacturing or process control requirements and related site documentation.