Description
The Final Quality Assurance role audits each batch record for completeness, compliance, and adherence to established procedures before releasing manufactured products. The position performs final product release using iFactory and Oracle, updates serial device information, supports Manufacturing and MQA in identifying quality risks, maintains controlled batch-record retention, and ensures compliance with FDA, EPA, OSHA, ISO, EEPC, and company requirements. Candidates need a high school diploma or GED, at least two years of experience in an FDA-regulated manufacturing environment, strong mathematical, computer, documentation, communication, troubleshooting, and teamwork skills; medical-device or pharmaceutical GMP experience is preferred.
