Supplier Quality Expert
About the job
- A bachelor's degree in Engineering, Quality Management, Life Sciences, or a related field is required.
- At least 2–4 years of experience in Supplier Quality, Quality Assurance, Quality Engineering, or a related function is required.
- Knowledge of ISO 13485 and medical device quality requirements is required.
- Experience with supplier audits, supplier qualification, and quality systems is required.
- Understanding of CAPA, Change Control, risk management, and validation processes is required.
- Proficiency in written and spoken English is required.
- The candidate must live in Antalya or be willing to relocate.
- 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, both on-site and remotely, 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 and customer complaints, and manage 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.
About the company
Fresenius Medical Care North America runs a network of dialysis facilities and outpatient labs to deliver coordinated kidney care for hundreds of thousands of patients. It also offers specialty pharmacy and laboratory services and manufactures a wide range of dialysis equipment, disposables, and renal drugs. The company treats patients by providing dialysis and related care at its clinics, supported by the equipment, supplies, and medicines it develops and distributes. FMCNA differentiates itself through its size and integration as the world's largest fully integrated renal company, with a nationwide network covering care delivery, drugs, labs, and manufacturing, aiming to provide high-quality, convenient access to comprehensive services across North America.
Company Size
11-50
Company Stage
Late Stage VC
Total Funding
$40.2M
Headquarters
Waltham, Massachusetts
Founded
1996
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Simplify's Take
What believers are saying
- Q2 2026 operating income rose 23%, showing transformation gains reached profitability.
- FME25+ delivered EUR 67 million savings in Q2 2026 and targets EUR 1.2 billion.
- Real-world evidence studies in July and August 2026 strengthen high-volume hemodiafiltration adoption.
What critics are saying
- The August 2026 outlook disappointed investors after dialysis growth stalled and shares fell 10%.
- FME25+ closed around 100 U.S. clinics in 2026, risking patient leakage to DaVita.
- AB 290 litigation and premium-assistance rules threaten U.S. reimbursement economics and legal spend.
What makes Fresenius Medical Care unique
- Fresenius Medical Care controls dialysis care, equipment, labs, and specialty pharmacy end-to-end.
- Its 5008X CAREsystem reached around 100 clinics and 100,000 treatments by May 2026.
- kinexus and TherapyWise deepen its software moat across home dialysis and kidney therapy.
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Benefits
- Professional Development Budget
- Conference Attendance Budget
- Flexible Work Hours