Kelly Mottet

Director, Quality Assurance and Regulatory Affairs @Innovative Trauma Care Inc

Edmonton, AB, CA

Responsible for directing and managing all aspects of the quality management system and regulatory as well as working cross-functionally to ensure production of high quality productsResponsible for all aspects of quality management systems, including- Serving as management representative and point of contact for regulatory bodies- Development, maintenance, and control of quality management system documentation to ISO, FDA and Health Canada standards- Maintaining complaint files and reporting of adverse events to regulatory agencies- Investigating and implementing corrective and preventative actions- Conducting supplier qualification audits- Conducting management review meetings- Maintaining risk management files to support design control processesSuccessfully worked cross functionally with product development team to develop new products and obtained necessary regulatory approvalsProvide leadership and guidance to organization in interpreting regulatory guidelines and implementing quality initiatives

University of Alberta

B.Sc Honors, Immunology and Infection

University of Alberta

Management Development Certificate, Business

University of Alberta

M.Sc, Virology