Orange County Metro Area, CA
Contractors will provide hands-on expertise to revise and document the Quality Management System, Clinical, Post-Market Surveillance, and Supplier Management processes as necessary for compliance with the European Union Medical Device Regulations (EU MDR). In addition, medical device technical files will be reviewed to ensure use of prohibited hazardous substances are in accordance with the limits set forth in the General Product Safety Requirements (Annex I), and records will be created as necessary to fulfill the requirements of the various Annexes.
Education & Qualification Requirements:
Minimum of a Bachelor s Degree is required, with preference for natural sciences or engineering
5+ years experience in Medical Device Quality Systems and/or Quality Assurance
Experience with Documentation Control and Change Control
First-hand experience with implementation of EU MDR requirements
Strong technical writing skills