Role: CAPA Facilitator Location: Reedsville, PA (Day 1 Onsite)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.
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.
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.
