Senior Quality Assurance Specialist/Management Representative
CurrentEnsure that the organizations’ Quality Management System conforms to customer, internal, ISO 13485, FDA, European Medical Devices Directives, Canadian Regulations, RDC 665/22 and other regulatory/legal requirements, Conduct and oversee the Internal Audit Program to establish and implement Corrective Actions and modifications to the QMS Documentation. Oversee Management of Change compliance. Report to management on the performance of the QMS. Oversees the maintenance of the QMS (Quality Management System) and ensures documentation (Quality Manual, SOPs, Work Instructions, GMP, GDP) in compliant with FDA regulations, ISO 13485:2016, 14971:2019 and MDR 93:42 Coordinate responses to any regulatory changes required. Advice executive leadership and company peers on improvement opportunities. Liaised with Managers/external-assessment bodies on all Quality Management System matters.