Maria T.

Work Experience Profile With 17 years of experience quality assurance and quality control officer in an ISO 13485 and MDSAP - MDSAP-certified medical device manufacturing company. Also handles Medical Device Regulatory Affairs, processes the acquisition, renewals, and amendments, and ensures maintenance of product Certificate of Medical Device Registration (CMDR). Has led a project related to product and equipment validations up to the acquisition of a certificate to operate from a certifying body like TUV SUD. Establish procedures, and protocols and conducted training for subordinates, performed document reviews, and supervised internal and external audits to ensure consistent compliance with the Quality Management System (QMS)