Working in the Advanced Manufacturing Group within the Transcatheter Heart Valve Business Unit

While working at Ossur, I had a wide breadth of experiences. In the Quality Department I worked within the Quality Management System to conform to ISO 103485 and complete the groundwork of many CAPAs. I also helped test products and materials to ASTM standards (ASTM F1831 for halo testing, ASTM D5169 & D5170 for hook and loop) on an Instron. In preparation of an external audit, I updated our training record and document control in Reliance. I also helped our Regulatory Manager work towards compliance for the new Medical Device Directive.