CAPA Facilitator

Role: CAPA Facilitator
Positions: 1
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.