Quality System & Compliance Expert

Fresenius Medical Care

Palazzo Pignano, Italy
**
Capa process leadership
Quality engineering activities
Validation and process change support
** Fresenius Medical Care is seeking a Quality System & Compliance Expert for its Palazzo Pignano plant in Italy. The ideal candidate will have experience in Quality Assurance within regulated industries, particularly medical devices, and will be responsible for managing the NC/CAPA process, supporting audits, and driving continuous improvement initiatives. **

Job Summary

  • As a Quality System and Compliance Expert, you will be responsible for leading and coordinating the CAPA process, Quality Engineering activities, and supporting validation activities, process changes, and Audits.
  • You will act as the primary SME for the NC/CAPA process, overseeing intake, investigation, root cause analysis, execution, and timely closure in line with KPIs.
  • The role requires reviewing and approving V&V plans and reports, supporting change control processes, and acting as a key reference point during audits.

Matching Summary

Match Score: 75

** Fresenius Medical Care is seeking a Quality System & Compliance Expert for its Palazzo Pignano plant in Italy. The ideal candidate will have experience in Quality Assurance within regulated industries, particularly medical devices, and will be responsible for managing the NC/CAPA process, supporting audits, and driving continuous improvement initiatives. **

Skills & Requirements

Must-have

  • CAPA process leadership
  • Quality Engineering activities
  • Validation and process change support
  • Audit support and follow-up
  • ISO 13485, ISO 14971, 21 CFR Part 820 knowledge

Nice-to-have

  • Proactive solution-oriented mindset
  • Cross-functional collaboration
  • Conflict management skills
  • Integrity and reliability

Key Requirements

  • Minimum 3 years of professional experience
  • Scientific, medical, or technical education
  • Fluent in Italian and English
  • Knowledge of single-use sterilized medical devices

Work Rights

Not specified

Tailored Resume

Cover Letter