Medical Technology Quality (M.S.)

David R. Koosman

David R. Koosman has more than 30 years of experience in the medical device industry. 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.

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.

Koosman has served two 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 is a member of senior management team.