QA Engineer - Process Control
Core
Review batch records, monitor manufacturing processes for compliance, and ensure finished product release in a medical device/pharmaceutical setting.
Role type
Quality Assurance Engineer (Process Control)
Builds
Compliance status of execution and finished product release
Domain
Medical devices / Pharmaceuticals
Deliverable
client delivery
Required skills
Batch record analysis, manufacturing process monitoring, root cause analysis (RCA, 5WHY), cross-functional coordination, regulatory assessment
Preferred skills
FDA audit experience, ISO9000/ISO13485/GMP/21CFR820/IVDD/IVDR knowledge
Technologies
Quality tools (RCA, 5WHY)
Responsibilities
Track and analyze production trends to improve batch record efficiency; monitor manufacturing processes to catch issues timely; coordinate cross-functional troubleshooting; evaluate finished product impact and make release decisions; perform external document assessment; develop procedures for new production issues.
Seniority
Mid-level, hands-on IC