The Poly Implant Protheses (PIP) breast implant scandal was one of the most notorious patient protection failures to have occurred in clinical research. The implants were made from a cheaper, industrial-grade silicone that was not approved for medical use and ruptured easily, leading to scarring and inflammation. The choice of a poor-quality material was life changing for these patients and it also led to significant regulatory change.
As a quality manager, you are responsible for establishing a company’s quality procedures and standards. You will also make sure that all production processes meet both national and international regulatory standards. When it comes to medical devices, the role of a quality professional involves developing and managing a product’s quality management system (QMS) and driving forward the manufacturer’s regulatory strategy.