Quality and Supplier Quality professional with over 10 years of experience in the medical device and automotive industries.
As a Certified Quality Auditor, I have led the full audit lifecycle (planning, execution, nonconformance reporting, and corrective-action closure) against ISO 9001, ISO 13485, ISO/IEC 17025, and FDA QSR requirements.
I have qualified international suppliers, delivered measurable scrap and cost-of-poor-quality reductions projects, and driven regulatory readiness across multiple sites. I bring a practical tools you can apply on the floor or in the audit room, not just theory.
Core Skills PFMEA, Control Plans, MSA, SPC, 8D, SCAR, NCMR, NPI | ISO 9001, ISO 13485, ISO/IEC 17025, FDA 21 CFR Part 820, EU MDR | Internal & Supplier Audit Leadership, MDSAP Support | Minitab, SAP, Oracle, Agile, OnePLM
