Randstad Documentation Control Specialist in Rockville, Maryland

Documentation Control Specialist


Rockville, MD Salary:

US$ 70,000 - US$ 80,000 per year Date Posted:

Tuesday, September 27, 2016 Experience:

3 years Job Type:


Reference #:



Randstad Engineering

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A growing BioMedical organization located in Rockville, MD is looking for a Senior Document Management Specialist. This is a direct hire opportunity. Relocation assistance provided for qualified candidates. APPLY NOW!

Responsibilities for the Documentation Control Specialist

  • Implement and manage the Document and Change Control processes

  • Implementation and management of an electronic Document Management System (eDMS) and electronic Learning Management System (eLMS) in support of all documentation, associated changes and employee training for in vitro diagnostic medical device (IVD) design, development and commercialization.

  • Responsible for the enterprise Change Control program for product and process changes that fall under the scope of the QMS program.

Requirements for the Documentation Control Specialist

  • Bachelor s degree required, plus knowledge of regulations in the field of medical devices, in-vitro diagnostics, molecular diagnostics, pharma or related industry.

  • Prior experience implementing and managing a document control system in an FDA regulated environment required.

  • Must have experience with the documentation requirements for establishing and managing changes to design history files (DHF), engineering drawings, manufacturing records, and quality system procedures.


  • Comprehensive benefit package

  • Relocation assistance for qualified candidates.

Job Number: 125573

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