Consumer Safety Officer, Medical Devices

Conduct domestic and foreign inspections of establishments producing medical devices and radiation-emitting products to evaluate compliance with regulations developed for public safety. The inspections are conducted in accordance with the US Food, Drug and Cosmetic Act and include the review of the quality systems at medical device manufacturing facilities.  Quality system inspections include focus on Corrective and Preventive Actions (CAPAs), process and production, management reviews, complaint handling, and design controls. We evaluate compliance with pre-market requirements and inspect facilities involved in developing new life-sustaining medical devices. . Inspection findings are documented in written reports and significant  deficiencies are documented  to support appropriate agency action ensuring regulatory compliance.