Quality System & Compliance Expert

We are seeking a Quality System and Compliance Expert to join our team in Palazzo Pignano, Italy. As a Quality System and Compliance Expert, you will be responsible for leading and coordinating CAPA process, Quality Engineering activities, and supporting validation activities, process changes, and Audits.

Requirements

• 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

Benefits

• 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