Quality System & Compliance Expert

Job description

Quality System and Compliance Expert 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! Summary about role As a Quality System and Compliance Expert, you will be part of Plant Quality Team and you will be responsible for leading and coordinating CAPA process, Quality Engineering activities and for supporting validation activities, process changes and Audits. Your Responsibilities NC/CAPA Management : Acts as the primary SME for the NC/CAPA process, overseeing intake, investigation, root cause analysis, execution, and timely closure in line with KPIs. Training & User Support : Delivers training on the NC/CAPA database to new users and provides ongoing support for investigations and customer complaint handling. Reporting & Escalation : Prepares and presents NC/CAPA metrics and performance updates to local and corporate management, defining escalation needs when required. Continuous Improvement : Identifies gaps and drives process and system improvements by collaborating with Quality, Engineering, Production, and other departments. Quality System & Compliance : Advises management on system effectiveness, supports quality reviews and risk assessments. V&V and Process Change : Reviews and approves V&V plans and reports and support change control processes. Audit Support : Acts as a key reference point during internal, corporate, notified body, and authority audits, ensuring proper follow-up of corrective actions. Documentation & Traceability : Ensures complete and compliant documentation, maintaining accurate records for audits, NC/CAPA processes, and QMS activities. Your Profile Completed scientific, medical, or technical education (or equivalent). Minimum 3 years of professional experience, including Quality Assurance, ideally in medical devices, pharmaceuticals, or another regulated industry. Strong knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and validation methods. Knowledge of single‑use sterilized medical devices. Fluent in Italian and English. Good IT skills (MS Office, SAP, SharePoint, procurement and quality databases such as NC/CAPA and document management systems). Strong communication and presentation skills, with the ability to build professional relationships at all organizational levels. Proactive, solution‑oriented mindset and ability to work cross‑functionally. Solid conflict‑management skills and ability to reach compliant, regulation‑aligned compromises. Demonstrated integrity, reliability, and decision‑making. Our Offer for you There 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 €36.000 and €42.000