CAPA Facilitator-Reedsville, PA (Hybrid)

Hi ,

Our client is looking for an CAPA Facilitator for Reedsville, PA (Hybrid) a project and below is the detailed requirement.

Job Title: CAPA Facilitator
Location: Reedsville, PA (Hybrid)

Responsibilities:

• Bachelor’s degree in Computer Science, Information Systems, Business, or a related field.
• Must have a CAPA Lifecycle Management.
• You should have a Nonconformance and Deviation Management.
• Must have a Root Cause Analysis Techniques.
• Good Experience in 8+ years of Medical Device Quality Systems experience.
• You should have a Minimum 3 years of CAPA management experience.
• Strong Experience supporting regulatory audits and inspections.
• Good Experience in eQMS and Quality Metrics Reporting.
• Must have a FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Good Experience to Manage CAPA lifecycle from initiation to closure.
• Must Monitor CAPA timelines, aging, and effectiveness.
• You should Facilitate CAPA review meetings and follow-ups.
• Must Review CAPA documentation for compliance.
• Good Experience to Support audit and inspection readiness activities.