Senior Supplier Quality Expert - MedTech (Italy)

Fresenius Medical Care AG; Palazzo Pignano; Remote; EUR 40,000 - 46,000; Full time

Job summary

Fresenius Medical Care AG is seeking a Senior Supplier Quality Expert CATS at the Palazzo Pignano plant in Italy. You will drive supplier quality management, audits, and CAPA across the Bloodlines division, collaborating with Procurement, Operations, R&D and Regulatory teams to ensure regulatory compliance and product excellence.

This onsite, full-time role requires a strong engineering or quality background, experience with GMP/ISO standards, and proficiency in QMS tools such as TrackWise.

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Quality Management, or related field.
• Several years of experience in Quality Management, especially Supplier Quality or Supplier Management.
• Experience in supplier qualification, audits, and quality system implementation.
• Proficient in GMP, ISO 9001/13485, MDSAP, CAPA, 8D, RCA and Change Control.

Responsibilities

• Lead Supplier Quality Management activities within Palazzo Pignano's Bloodlines division.
• Plan and conduct on-site and remote supplier audits per ISO 13485 and regulatory requirements.
• Drive supplier qualification, auditing, development, and approval of changes.
• Investigate deviations, CAPA, and supplier performance issues with data-driven improvements.
• Collaborate with Procurement, Operations, R&D, Regulatory Affairs and suppliers.

Skills

GMP knowledge

Quality management

ISO 9001

ISO 13485

MDSAP

CAPA

8D

Risk management

Change Control

Process validation

Lean/Six Sigma

Excel

SAP

QMS tools (TrackWise)

Education

Bachelor's degree in Engineering, Biomedical Engineering, Quality Management, or related technical field

Tools

Excel

SAP

TrackWise

Job description

Fresenius Medical Care AG is seeking a Senior Supplier Quality Expert CATS at the Palazzo Pignano plant in Italy. You will drive supplier quality management, audits, and CAPA across the Bloodlines division, collaborating with Procurement, Operations, R&D and Regulatory teams to ensure regulatory compliance and product excellence.

This onsite, full-time role requires a strong engineering or quality background, experience with GMP/ISO standards, and proficiency in QMS tools such as TrackWise.