Experteer Overview In this role, you join the Plant Quality Team to lead CAPA execution, quality engineering activities, and support validation, process changes, and audits. You will drive continuous improvement across Quality, Engineering, and Production, ensuring robust QMS and effective risk management. The role offers cross-functional collaboration with global teams and exposure to regulatory audits, shaping product quality for dialysis devices. This position connects you to a meaningful mission in patient care at scale. Retribuzione / Benefits NC/CAPA management as primary SME: intake, investigation, root cause analysis, execution, closure Deliver training on NC/CAPA database and support investigations and complaint handling Prepare and present NC/CAPA metrics to management; define escalations Identify gaps and drive process and system improvements with cross-functional partners Advise management on system effectiveness and support quality reviews and risk assessments Review and approve V&V; plans and reports; support change control processes Act as a reference during internal,



corporate, and notified body audits and ensure corrective actions Ensure complete, compliant documentation and traceability for audits, NC/CAPA, and QMS activities Responsabilità Completed scientific, medical, or technical education (or equivalent) Minimum 3 years of experience in Quality Assurance, ideally in medical devices or 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, Share Point, procurement and quality databases such as NC/CAPA and document management systems) Strong communication and presentation skills with ability to build cross-organizational relationships Proactive, solution-oriented mindset and ability to work cross-functionally Solid conflict-management skills and ability to reach compliant, regulation-aligne

📌 Quality system (Italia)
🏢 Experteer Italy
📍 Italia