Gene has more than 25 years of experience in many facets of R&D, quality and regulatory. He has spent most of the last ten years working specifically in medical devices for companies such as Medtronic, Covidien, and Volcano Corporation.
Gene comes to Myraqa from a career as an independent consultant where he provided quality and regulatory consulting related to audits, CAPAs, NCRs, IQ/OQ/PQs, MDD essential requirements, submissions and risk management.
Gene holds an MBA from the University of Minnesota and a BS from the University of Wisconsin. Gene also holds an array of professional certifications, including Certified Quality Manager (CQM), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), and ISO 9000 Quality Systems Lead Auditor (QSLA).