This role involves leading the NC/CAPA process, including intake, investigation, root cause analysis, and timely closure in line with KPIs
Job Summary
This role involves leading the NC/CAPA process, including intake, investigation, root cause analysis, and timely closure in line with KPIs.
The position requires advising management on system effectiveness and supporting quality reviews and risk assessments within a global healthcare leader.
Candidates will act as a key reference point during internal, corporate, notified body, and authority audits to ensure proper follow-up of corrective actions.
Matching Summary
This role involves leading the NC/CAPA process, including intake, investigation, root cause analysis, and timely closure in line with KPIs.
Skills & Requirements
Must-have
NC/CAPA process management
ISO 13485 and ISO 14971 knowledge
21 CFR Part 820 compliance
Validation and verification methods
Single-use sterilized medical devices
Italian and English fluency
Nice-to-have
SAP and SharePoint proficiency
Cross-functional collaboration skills
Conflict management abilities
Proactive solution-oriented mindset
Strong presentation skills
Key Requirements
Minimum 3 years professional experience in Quality Assurance
Completed scientific, medical, or technical education