Quality Assurance Engineer - Auburn
3 weeks ago
Job summary
Lead and execute IQ/OQ/PQ validation activities for equipment processes and product introductions Develop review and approve Validation Master Plans protocols and reports Maintain compliance with ISO 13485 FDA 21 CFR Part 820 other applicable regulations/standards and internal quality system procedures Drive root cause investigations implement effective Corrective Preventive Actions CAPA Conduct risk management activities including PFMEA Support internal audits supplier audits regulatory inspections as needed Analyze quality data trends recommend improvements to reduce defects nonconformances Ensure lot traceability documentation accuracy compliance with Device History Records DHR
Job description
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