Job Summary:Facilitate and manage the end-to-end CAPA process to ensure timely investigation, implementation, effectiveness verification, and closure of quality issues. Coordinate cross-functional teams, monitor CAPA metrics, support audit readiness activities, and maintain compliance with FDA and ISO quality system requirements.
Key Responsibilities:- Manage CAPA lifecycle from initiation to closure.
- Monitor CAPA timelines, aging, and effectiveness.
- Facilitate CAPA review meetings and follow-ups.
- Review CAPA documentation for compliance.
- Support audit and inspection readiness activities.
Preferred Qualifications:- Bachelor's degree in Engineering or Life Sciences.
- 8+ years of Medical Device Quality Systems experience.
- Minimum 3 years of CAPA management experience.
- Experience supporting regulatory audits and inspections.
Required Skills:- CAPA Lifecycle Management.
- Nonconformance and Deviation Management.
- Root Cause Analysis Techniques.
- eQMS and Quality Metrics Reporting.
- FDA 21 CFR Part 820, ISO 13485, ISO 14971.
