Senior Supplier Quality Expert CATS

Fresenius Kidney Care; 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

Senior Supplier Quality Expert CATSFresenius Medical Care AG uses necessary cookies on this career website to enable core functionality such as security, network management and accessibility. Moreover, you can accept an additional set of cookies for the application process and modification (Autofill with Resume, My Information, My Experience, Application Questions, Voluntary Disclosures, Self-Identify and Review). If you need more information, please see our cookie declaration and check your browser settings to uninstall undesired cookies, but be aware that this may affect how the website functions.### Senior Supplier Quality Expert CATSApply: Hybrid: ITA Palazzo Pignano - Plant: Full time: Posted Today: End Date: January 31, 2027 (30+ days left to apply): R0268837# **Senior Supplier Quality Expert CATS****Location:** Palazzo Pignano (CR) **Work Model:** Onsite 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 **Information about plant**Located in northern Italy, our Palazzo Pignano plant serves as a key center for the production and development of dialysis-related medical devices. With more than 550 employees, the plant specializes in manufacturing both peritoneal dialysis (PD) disposables and hemodialysis (HD) bloodline components. It combines large-scale production capabilities with strong R&D and engineering expertise. By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we’re not only driving innovation — we’re also creating meaningful change for patients worldwide.Join our passionate team and be part of this global impact! ## The OpportunityAs a **Senior Supplier Quality Expert CATS**, you will play a key role in driving Supplier Quality Management activities in Palazzo Pignano manufacturing site. You will be responsible for ensuring supplier compliance, product quality, and continuous improvement throughout the supply chain, while supporting strategic supplier development and regulatory compliance initiatives.Working closely with Procurement, Operations, R&D, Regulatory Affairs, Supplier Engineering, and external suppliers, you will contribute to maintaining the highest quality standards for our medical device manufacturing operations. # **Your Responsibilities**## Supplier Quality Management* Lead Supplier Quality Management activities within the Bloodlines division.* Implement and maintain Supplier Quality Assurance systems in alignment with global FMC policies and procedures.* Drive supplier qualification, selection, auditing, and continuous development programs.* Ensure supplier compliance with quality requirements and regulatory standards.* Support supplier process validation, risk management, and change management activities.* Assess and approve supplier-related changes through Change Control processes. ## Supplier Audits & Compliance* Plan and conduct on-site and remote supplier audits in accordance with ISO 13485 and applicable regulatory requirements.* Monitor supplier performance and quality metrics.* Ensure material and product quality across the entire supply chain.* Support site and supplier transfer activities.* Collaborate with Regulatory Affairs and Quality teams to ensure ongoing compliance. ## Quality Systems & Continuous Improvement* Investigate and manage supplier-related deviations, complaints, and CAPA activities.* Analyze supplier performance data and develop improvement plans.* Prepare and present supplier performance reviews and management reports.* Identify quality risks and implement corrective and preventive actions.* Promote continuous improvement initiatives and best practices across the supplier network. ## Stakeholder Collaboration* Act as a key quality partner for Procurement, Operations, R&D, Regulatory Affairs, Supplier Engineering, and manufacturing sites.* Support SOP deployment and training activities across the assigned plants.* Provide expert guidance on supplier quality topics and quality management processes.* Collaborate with suppliers, notified bodies, and regulatory agencies when required. # **Your 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.* Strong knowledge of supplier quality tools and methodologies.* Experience working in a regulated environment, preferably within MedTech, pharmaceutical, or healthcare industries.* Fluent English; German language skills are considered a strong advantage. ## Technical & Professional Skills* Strong knowledge of GMP requirements and quality management systems.* Good understanding of ISO 9001, ISO 13485, MDSAP, and applicable regulatory requirements.* Practical experience with CAPA, 8D, Root Cause Analysis, FMEA, and Change Control processes.* Experience with process validation in medical device manufacturing.* Knowledge of manufacturing commodities such as plastics, chemicals, electronics, or injection molding.* Advanced skills in Excel, SAP, KPI analysis, reporting, and dashboard creation.* Experience with TrackWise or equivalent Quality Management Systems is preferred.* Knowledge of Lean, Six Sigma, or Continuous Improvement methodologies is an advantage.* Project Management experience is highly desirable. ## Personal Competencies* Strong analytical mindset and structured problem-solving approach.* Excellent communication and stakeholder management skills.* Ability to influence, moderate discussions, and drive decisions.* High level of accountability and organizational capability.* Team-oriented attitude with strong intercultural awareness.* Ability to work effectively in a global and matrix organization. ## Our Offer for YouThere is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey. * Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world* Individual opportunities for self-determined career planning and professional development* A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one* A large number of committed people with a wide range of skills, talents and experience* The indicative annual base salary range for this position is between €40.000 and €46.000