ph3bSenior Supplier Quality Expert CATS /b /h3pbLocation: /b Palazzo Pignano (CR)br/bWork Model: /b Onsite /pbr/pAt 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. /pbr/pWithin 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. /ppOur values guide how we work: /pulliWe Care for our patients, each other, and our communities /liliWe Connect across teams and borders to deliver excellence together /liliWe Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation /li /ulbr/pbInformation about plant /b /ppLocated 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 RD 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. /ppJoin our passionate team and be part of this global impact! /pbr/h3The Opportunity /h3pAs a bSenior Supplier Quality Expert CATS /b, 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. /ppWorking closely with Procurement, Operations, RD, Regulatory Affairs, Supplier Engineering, and external suppliers, you will contribute to maintaining the highest quality standards for our medical device manufacturing operations.



/pbr/h3bYour Responsibilities /b /h3h3Supplier Quality Management /h3ulliLead Supplier Quality Management activities within the Bloodlines division. /liliImplement and maintain Supplier Quality Assurance systems in alignment with global FMC policies and procedures. /liliDrive supplier qualification, selection, auditing, and continuous development programs. /liliEnsure supplier compliance with quality requirements and regulatory standards. /liliSupport supplier process validation, risk management, and change management activities. /liliAssess and approve supplier-related changes through Change Control processes. /li /ulbr/h3Supplier Audits Compliance /h3ulliPlan and conduct on-site and remote supplier audits in accordance with ISO 13485 and applicable regulatory requirements. /liliMonitor supplier performance and quality metrics. /liliEnsure material and product quality across the entire supply chain. /liliSupport site and supplier transfer activities. /liliCollaborate with Regulatory Affairs and Quality teams to ensure ongoing compliance. /li /ulbr/h3Quality Systems Continuous Improvement /h3ulliInvestigate and manage supplier-related deviations, complaints, and CAPA activities. /liliAnalyze supplier performance data and develop improvement plans. /liliPrepare and present supplier performance reviews and management reports. /liliIdentify quality risks and implement corrective and preventive actions. /liliPromote continuous improvement initiatives and best practices across the supplier network. /li /ulbr/h3Stakeholder Collaboration /h3ulliAct as a key quality partner for Procurement, Operations, RD, Regulatory Affairs, Supplier Engineering, and manufacturing sites. /liliSupport SOP deployment and training activities across the assigned plants. /liliProvide expert guidance on supplier quality topics and quality management processes. /liliCollaborate with suppliers, notified bodies, and regulatory agencies when required. /li /ulbr/h3bYour Profile /b /h3ulliBachelor's degree in Engineering, Biomedical Engineering, Quality Management, or a related technical field. /liliSeveral years of experience in Quality Management,



preferably in Supplier Quality or Supplier Management. /liliExperience in supplier qualification, audits, supplier development, and quality system implementation. /liliStrong knowledge of supplier quality tools and methodologies. /liliExperience working in a regulated environment, preferably within MedTech, pharmaceutical, or healthcare industries. /liliFluent English; German language skills are considered a strong advantage. /li /ulbr/h3Technical Professional Skills /h3ulliStrong knowledge of GMP requirements and quality management systems. /liliGood understanding of ISO 9001, ISO 13485, MDSAP, and applicable regulatory requirements. /liliPractical experience with CAPA, 8D, Root Cause Analysis, FMEA, and Change Control processes. /liliExperience with process validation in medical device manufacturing. /liliKnowledge of manufacturing commodities such as plastics, chemicals, electronics, or injection molding. /liliAdvanced skills in Excel, SAP, KPI analysis, reporting, and dashboard creation. /liliExperience with TrackWise or equivalent Quality Management Systems is preferred. /liliKnowledge of Lean, Six Sigma, or Continuous Improvement methodologies is an advantage. /liliProject Management experience is highly desirable. /li /ulbr/h3Personal Competencies /h3ulliStrong analytical mindset and structured problem-solving approach. /liliExcellent communication and stakeholder management skills. /liliAbility to influence, moderate discussions, and drive decisions. /liliHigh level of accountability and organizational capability. /liliTeam-oriented attitude with strong intercultural awareness. /liliAbility to work effectively in a global and matrix organization. /li /ulbr/h3Our Offer for You /h3pThere 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. /pbr/ulliWhether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world /liliIndividual opportunities for self-determined career planning and professional development /liliA corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one /liliA large number of committed people with a wide range of skills, talents and experience /liliThe indicative annual base salary range for this position is between €40.000 and €46.000 /li /ul /p #J-18808-Ljbffr

📌 Senior Supplier Quality Expert CATS (Palazzo Pignano)
🏢 Fresenius Medical Care
📍 Palazzo Pignano