Medical Device Document Control Administrator

St. Louis, MO

Job ID: 127030 Industry: Med

Medical Device Document Control Administrator

 

Environment:

Our client is in the medical device industry.  They develop and manufacture implantable medical  devices.  The client is in need of a consultant with medical device background to assist with document controlling duties.

Principle Duties and Responsibilities:

·          The consultant will be responsible for managing the document control process for our clients quality system documents

Day to day responsibilities include:

This consultant will be responsible for assigning the proper document workflow and approval cycle based on document type, while keeping in mind extreme detail. This person will need to assign the appropriate approvers/reviewers based on each individual document type. They will also add and edit descriptions of changes, or any other information contained on the document change notices. This consultant should be able to manage outstanding change orders and feel comfortable contacting all reviewers/approvers. This is in order to facilitate timely processing of documents. They will be tasked with the proofreading of Quality Systems documents to identify any/all errors and make proper changes and corrections to achieve sufficiency. The consultant may also be asked to assist with CAPA and product complaint handling processes in their daily routine.

 

Required:

- 3-5 years’ experience in the manufacturing environment related to document control of quality, in a regulated Medical Device environment

- Attention to detail

- Ability to manage multiple tasks simultaneously

- FDA, ISO, AS9100, MIL, etc

- Excellent communication skills including high proficiency in the English language (read/write/speak)

- Experience using MasterControl or other similar electronic QMS system for change management (Trackwise, Documentum, Agile, etc.)

Job Type: Contract 

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