Medical Device QS Document Control SME

Los Angeles, CA

Job ID: 123906 Industry: Med

 

Medical Device Quality Systems Document Control SME

Environment:

Our client is a leading medical device manufacturer of Class II devices. In need of Quality Systems Document Controller to come in and help revamp the client document control process.

Roles/Responsibilities:

The client currently has a 17 year old document control system that is primarily still paper based and uploaded into a common share drive. Looking for someone with 10+ years of Document Control experience to come in and help map out a new process and what it would take to potentially move over to an electronic based system. Some of the issues they currently face are a lack of number systems, the nomenclature is off, the linkage of the documents are outdated and there is no harmonized document structures. There are approximately 20, 000 Quality System Documents being affected. This person must come from the medical device background and have experience revamping entire systems as well as all the necessary compliance requirements as it pertains to Doc Control.

Required:

-      7-10+   yrs experience in Medical Device

-     Quality Systems Document Control SME

-     Auditing Experience

-     Process Mapping

Job Type: Contract 

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