Sr. Software Quality Engineer
MEDIcept, Inc.
Gregg Van Citters has over 16 years of experience in the medical device industry, from clinical research and operations through quality management systems and design quality engineering. Although his focused area of expertise includes Risk Management, Design Control and Production & Process Control, he has broad experience in QMS development and implementation, including EU MDR and IVDR updates and related training. In addition, he has assisted clients in developing compliant Quality Management Systems and has performed Quality Management System audits of clients and suppliers.
As a Software Quality Engineer at MEDIcept, Gregg is responsible for supporting client system and software projects from development and security lifecycle planning through verification and validation testing. He supports software risk management including usability, security and safety considerations throughout the development lifecycle.
Before joining MEDIcept, Gregg worked as a design quality engineer and as an independent consultant. Throughout his career, Gregg has held various positions including software engineer, drug development research professor, clinical research trainer, Lean/Six Sigma Black Belt, and quality systems snior manager.
Gregg holds B.S. degrees in Chemistry and Mathematics from Norwich University; an M.S. degree in Human Nutrition from California Polytechnic University Pomona and a Ph.D. from University of Southern California. He is a member of ASQ, including the Biomedical Division and the Los Angeles group. He has held various volunteer leadership positions with community groups including Toastmasters International, Association for Talent Development (formerly ASTD) and the California Dietetic Association. He is the coauthor of numerous original research articles, review papers and book chapters in nutrition, gastroenterology and diabetes.
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Cybersecurity: Integrating Medical Device Cybersecurity in the Quality Management System
Wednesday, May 8, 2024
14:00 – 15:00 CEST