CAPA Facilitator

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.