Medical Device Document Control Specialist

Boston, MA

Job ID: 128090 Industry: Med

 

Medical Device Document Control Specialist 

Environment:

Our client is a large manufacturer of Diagnostic products. They are currently in need of a Document Control Specialist to support a global documentation update initiative for a new facility in China.

Responsibilities:

The Document Control Specialist should come from the Life Sciences industries (Medical Device, Diagnostics, Pharmaceutical, Biologics, etc.). Responsibilities include:
  • Coordinating document update activities  cross-functionally  with project teams in Manufacturing, Technical Operations, Engineering, Quality, etc.
  • Review and update document formats before sending them for translation.
  • Working closely with Translation Agency to monitor and track  document translation progress to meet the project timeline.
  • Assign and track technical document reviews, and confirm with other project SMEs/stakeholders after the translation is complete.
  • Final release and implementation of translated documents in China.

Required Experience:
  • Life Sciences (Medical Device, Pharma, Diagnostics, Biologics, etc.)
  • Document Control
  • Change Control
  • ISO 13485 & 21 CFR Part 820

Plus:
  • It would be a plus if candidate can speak, read, or write Mandarin, but is not a requirement.

Job Type: Contract  

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