Supplier Quality Expert CATS

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, Quality Management, Life Sciences, or a related field.
• •At least 2-4 years of experience in Supplier Quality, Quality Assurance, Quality Engineering, or a related function.
• •Knowledge of ISO 13485 and medical device quality requirements.
• •Experience with supplier audits, supplier qualification, and quality systems.
• •Understanding of CAPA, Change Control, risk management, and validation processes.
• •Strong analytical and problem-solving skills.
• •Effective communication and stakeholder management abilities.
• •Proficiency in English, both written and spoken.
• •Living in Antalya or willing to relocate.

KEY RESPONSIBILITIES

• •Manage Supplier Quality activities within the Bloodlines division.
• •Implement Supplier Quality Assurance systems across assigned regions and manufacturing plants in alignment with global policies and standard operating procedures (SOPs).
• •Deploy Supplier Quality SOPs and conduct related training activities at manufacturing sites.
• •Lead supplier qualification, selection, evaluation, and continuous development processes.
• •Plan and perform supplier audits (on-site and remote) in accordance with ISO 13485 and applicable regulatory requirements.
• •Ensure raw material and product quality throughout the supply chain.
• •Investigate, analyze, and manage supplier-related: Deviations Customer complaints Corrective and Preventive Action (CAPA) processes
• •Assess and approve supplier-related changes through established Change Control procedures.
• •Support supplier and manufacturing site transfer projects.
• •Collaborate with suppliers on process validation, risk management, and change management activities.
• •Monitor supplier performance metrics and drive continuous improvement initiatives.
• •Prepare and present quality reports, trend analyses, and process improvement recommendations.