Medical Device senior engineer (Somerville, MA)

Medical Device senior engineer

s www.globalchannelmanagement.com jobopeningsjobs(at)globalchannelmanagement.co mMedical Device senior engineer needs 5 years experience in Medical Device Quality Systems and or Quality Assurance. Medical Device senior engineer requires Experience with Documentation Control and Change Control. First-hand experience with implementation of EU MDR requirements. Strong technical writing skills. Bachelor s Degree is required with preference for natural sciences or engineering. Medical Device senior engineer dutiesprovide 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). I 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.