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.