John Kotwick - Director, Regulatory Affairs & Quality Control
John received a B.S. in mathematics, an M.S.E. in mechanical engineering, and an M.S. in human physiology, all from Wayne State University. He has 30 years experience with medical devices, working for Wayne State University, University of Pennsylvania, Biolectron, Bristol Myers-Squibb, Bissell Healthcare, Medtronic, Michigan Instruments, Tech Group, and Medbio.
Jack Faasen - Quality Inspector
Jack received a B.A. from Michigan State University. He has been involved in the medical device industry since 2004, with experience as a lean manufacturing coordinator. His areas of competence are metrology for production releases; audits of device history files; and, internal audits for all areas of ISO 13485:2003 compliance.
Darrel Lanning - Senior Quality Technician
Darrell received a bachelor's degree from Northwood University; Certificate in quality technology from Ferris State University. He has been involved in the medical device industry since 1994. His work experience includes ATEK Medical (formerly DLP/Medtronic), and Tech Group/West Pharma. His areas of competence are calibration and metrology; environmental, health, and safety; outsource supplier coordination; quality engineering especially in quality plans, statistics, and validation/qualifications.