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Medical Device senior engineer

Company: Global Channel Management, Inc.
Location: Elizabeth
Posted on: November 30, 2019

Job Description:

Medical 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. Bachelors Degree is required, with preference for natural sciences or engineering. Medical Device senior engineer duties 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). 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.

Keywords: Global Channel Management, Inc., Elizabeth , Medical Device senior engineer, Healthcare , Elizabeth, New Jersey

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