The role involves leading the NC/CAPA process, including intake, investigation, root cause analysis, and timely closure in line with KPIs
Job Summary
The role involves leading the NC/CAPA process, including intake, investigation, root cause analysis, and timely closure in line with KPIs.
Candidates will act as a key reference point during internal, corporate, notified body, and authority audits to ensure proper follow-up of corrective actions.
Fresenius Medical Care offers individual opportunities for self-determined career planning within a culture that values innovative thinking and integrity.
Matching Summary
The role involves leading the NC/CAPA process, including intake, investigation, root cause analysis, and timely closure in line with KPIs.
Skills & Requirements
Must-have
ISO 13485 and ISO 14971 knowledge
CAPA process management expertise
Validation and V&V plan review
Audit support for notified bodies
Fluent Italian and English skills
Nice-to-have
Strong conflict-management skills
Cross-functional collaboration mindset
Experience with single-use sterilized devices
Proactive solution-oriented approach
Key Requirements
Minimum 3 years professional experience
Scientific, medical, or technical education
Experience in regulated industries like medical devices