Senior Supplier Quality Expert CATS

About the role

Fresenius Medical Care is hiring a Senior Supplier Quality Expert for its Palazzo Pignano plant in northern Italy, where dialysis-related medical devices are produced. Working onsite, you will lead Supplier Quality Management activities in the Bloodlines division, ensuring supplier compliance, product quality and continuous improvement, and supporting supplier development and regulatory compliance. The role works closely with Procurement, Operations, R&D, Regulatory Affairs, Supplier Engineering and external suppliers.

Key responsibilities

• Lead supplier quality management in the Bloodlines division and maintain supplier quality assurance systems aligned with global FMC policies.
• Drive supplier qualification, selection, auditing and development, and support process validation, risk management and change control.
• Plan and run on-site and remote supplier audits under ISO 13485, monitor supplier performance metrics and support site and supplier transfers.
• Investigate supplier deviations, complaints and CAPA, analyse performance data, prepare supplier reviews and reports, and implement corrective and preventive actions.
• Support SOP deployment and training, and act as a quality partner to Procurement, Operations, R&D, Regulatory Affairs and manufacturing sites.

Required profile

• Bachelor's degree in Engineering, Biomedical Engineering, Quality Management or a related technical field.
• Several years of experience in Quality Management, preferably in Supplier Quality or Supplier Management.
• Experience in supplier qualification, audits, supplier development and quality system implementation.
• Experience in a regulated environment, preferably in MedTech, pharmaceuticals or healthcare.
• Fluent English; German is a strong advantage.

Required skills

• GMP and quality management systems; ISO 9001, ISO 13485, MDSAP and regulatory requirements.
• CAPA, 8D, root cause analysis, FMEA and change control; process validation.
• Excel, SAP, KPI analysis, reporting and dashboards; TrackWise or similar QMS preferred.
• Lean, Six Sigma or continuous improvement; project management experience highly desirable.

What we offer

• Indicative annual base salary of EUR 40,000 to 46,000.
• Opportunities for self-directed career planning and professional development.
• A corporate culture that encourages innovative thinking and a diverse, committed team.