Qa Engineering Intern
Current- Managed Supplier Quality Management re-approval process- Active QA member on US FDA audit response task force- Familiar with FDA's 21CFR Part 820 regulations and ISO 13485:2003 and 2016- Actively engaged in Quality Management System (QMS) data trending for numerous (150+) Medical Device Suppliers/Vendors- Basic understanding of Process and Software Validation strategies (IQ, OQ, PQ, and PPQ)- CAPA Process- root cause analysis and effectiveness monitoring reviews for Exactech multi-site system