ph3Experteer Overview /h3pIn 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.
/ph3Retribuzione / Benefits /h3ulliNC/CAPA management as primary SME: intake, investigation, root cause analysis, execution, closure /liliDeliver training on NC/CAPA database and support investigations and complaint handling /liliPrepare and present NC/CAPA metrics to management; define escalations /liliIdentify gaps and drive process and system improvements with cross-functional partners /liliAdvise management on system effectiveness and support quality reviews and risk assessments /liliReview and approve VV plans and reports; support change control processes /liliAct as a reference during internal, corporate, and notified body audits and ensure corrective actions /liliEnsure complete, compliant documentation and traceability for audits, NC/CAPA,



and QMS activities /li /ulh3Responsabilità /h3ulliCompleted scientific, medical, or technical education (or equivalent) /liliMinimum 3 years of experience in Quality Assurance, ideally in medical devices or regulated industry /liliStrong knowledge of ISO *****, ISO *****, 21 CFR Part 820, and validation methods /liliKnowledge of single-use sterilized medical devices /liliFluent in Italian and English /liliGood IT skills (MS Office, SAP, SharePoint, procurement and quality databases such as NC/CAPA and document management systems) /liliStrong communication and presentation skills with ability to build cross-organizational relationships /liliProactive, solution-oriented mindset and ability to work cross-functionally /liliSolid conflict-management skills and ability to reach compliant, regulation-aligned compromises /liliDemonstrated integrity, reliability, and decision-making /li /ulh3Requisiti fondamentali /h3ulliprofessional development opportunities /lilicareer planning and progression /liliinnovative culture /liliglobal impact in patient care /lilicross-functional collaboration /lilisupportive team environment /li /ul /p #J-*****-Ljbffr

📌 Quality System & Compliance Expert (Bardi)
🏢 Experteer Italy
📍 Bardi