Fifteen years of experience managing quality systems for various types of companies, including medical device software, medical devices, laboratory and clinical trial service companies. Additional experience as a clinical trial project manager and as a lab technologist for biomarker, in-vitro diagnostic laboratories, and blood bank laboratories.
Supported numerous audits from accrediting bodies, Joint Commission, pharmaceutical companies and more.
Auditor certified in ISO 13485:2016, EU MDR and MDSAP. Experience with 21 CFR 820, 21 CFR Part 11, and software verification and validation.