Medical Device Quality Auditor

Boston, MA

Job ID: 131317 Industry: Medical Device



Medical Device  Sr. Quality Auditor (MDSAP)


Summary: Our client is a leading maker of medical devices and supplies as well as surgical products. Currently looking for a quality auditor. To perform an independent MDSAP/ISO 13485 gap assessment of their current processes.


Responsibilities:  The auditor will have to have had experience conducting ISO 13485 audits and will be well-versed in all current FDA rules and regulations as it pertains to ISO 13485: 2016. They will be a quality auditor, with very heavy experience in the medical device industry. They need to be able to manage themselves and have experience with comprehensive quality audits and to provide a detailed follow-up Audit Report at the conclusion of the audit.



·          Quality Auditing: 8-10 years

·          Medical Device: 8-10 years

·          ISO 13485: 2016 certified


Job Type: Contract 

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