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CAPA Facilitator (Medical Device Quality Systems )
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What they do
A Quality Assurance Manager focuses on prevention of mistakes and defects in manufacturing products. Develops procedures to ensure that quality standards are maintained. Manages all steps related to quality assurance as part of the quality management strategy of a company. May involve leadership of a team of quality assurance supervisors, specialists, and other associated staff members.
$108,441 / year median in Pennsylvania
-1% projected decline
Job Description
CAPA Facilitator (Medical Device Quality Systems ) at AppLab Systems, Inc CAPA Facilitator (Medical Device Quality Systems ) at AppLab Systems, Inc in YEAGERTOWN, Pennsylvania Posted in about 22 hours ago.
Type:
full-time
Role:
CAPA Facilitator Location:
Reedsville, PA Type:
FTE/ Contract Job Description:
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. 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. 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. 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.