MedTech Safety
Bio
Steve Gompertz (CMQ/OE, CMDA, RAC-US, CMII) is a leader in Quality Systems management with over 30 years of experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the medical technology industry providing guidance on quality systems and regulatory compliance.
Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, medical device auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in the “M.S. in Medical Technology Quality” program. He is a Distinguished Speaker with the Society for Quality Assurance (SQA) and was awarded the 2023 Charles W. Britzius Distinguished Engineer Award by the MN Federation of Engineering, Science, and Technology Societies (MFESTS).