Document Control Specialist

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Document Control Specialist

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    Document Control Specialist
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Document Control Specialist 

We are looking for a Document Control Specialist to join a leading electronic company launching a startup medical device division for the first time. As they enter the medical device arena, they are looking for someone who understands how to properly create and maintain documentation within a QMS. 

  • Maintain the company’s documentation related to the Quality Management System for Medical Devices (QMS-MD). Manage and execute all PCNs/ECNs, Standards Library, Files of Protocols and Reports, Supplier qualification files.
  • Responsible for QMS-MD records and corporate QMS-MD Procedures.
  • Aid in the development of Design History File (DHF) content, and coordinate document control activities within the emerging business group.
  • Coordinate activities related to the QMS-MD Engineering Change Notice (ECN) process.
  • Input and update BOMs. 
  • Assist with procedure development and review, validation protocols, and similar documents necessary for the continued compliance of the quality system.
  • Maintain training log.
  • Support preparation for customer audits.
  • Occasional technical writing.
  • Assist staff with product testing, inquiries, customer complaints and support as needed.
  • Coordinate Corrective and Preventive action activities. Maintain all CAPA, NCMR, and Complaint Files.
  • Maintain HIPPA records related to clinical trials.


  • Experience: Minimum 3 years experience required in documentation management for medical devices required. Excellent grasp of medical device quality systems including FDA QSR and ISO 13485

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