Medical Device Quality Auditor

Denver, CO

Job ID: 123234 Industry: Med

Medical Device Quality Auditor

Environment:
Our client is a  developer and international supplier of blood component and cellular technologies. They need someone to help out at their new manufacturing site and conducting a mock FDA assessment.

Job Duties/Responsibilities:

Our client has a new facility in Vietnam and they are looking for a QMS Expert to complete a mock FDA. Purpose is readiness assessment for FDA inspection. They need someone who has pharmaceutical and medical device experience, but more heavily weighted toward drugs. The team believes they will be about 60% ready, so they want a check on direction and scope of remaining work. They need someone that has experience working with US and International regulations. Past experience doing FDA audits would be ideal.

Required:

Medical Device/ Pharmaceutical

QMS

FDA Audit

Must be willing  to travel Internationally 

Job Type: Contract 

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