David R. Koosman has nearly 40 years of experience in the medical device industry.
David is a graduate from the University of Minnesota with a degree in Mechanical Engineering, He has also earned certifications in Quality Engineering, Lead Auditing for ISO Quality Management Systems, and various other certificates in the Medical Device field.
An employee of American Medical Systems from 1981 to 2006, he was responsible for various areas in quality assurance compliance including — CAPA, returned component analysis, documentation, auditing, validation, and verification systems. David Managed various technical departments at AMS including Quality Engineering, Operations Engineering, and Microbiological Services
He also served as the technical integration manager for acquisitions, packaging/sterilization lead for operations and quality assurance groups, and as team lead for ISO 9001/13485 certification.
He worked four years as Quality Assurance Director at Sil-Pro. He was responsible for all quality assurance activities including — customer audits (typically 25+ per year), V&V activities, gage R&R activities, first articles, training, trending, and customer complaints.
David had served nearly four years as Director of Quality Assurance at Uromedica-Inc. His duties included — management representative, all areas of compliance to ISO 13485, the Canadian regulations and QSR. In addition, he provides support for PMA submission, international registrations, conducts quality management meetings and was a member of the Senior Management Team.
David has also served as a technical consultant providing support with Quality Systems and Engineering Management for international start-up Medical device companies as well as domestic startups. He has also served the last eight years in our Medical Technology and Quality (MTQ) Program in both a teaching capacity as well as an originating author to several of the MTQ courses.