Senior Document Control Specialist

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Senior Document Control Specialist

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  • Title:

    Senior Document Control Specialist
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  • Assignment Type:

    Direct Hire
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Our client located in Cambridge, Ma is looking for a Senior Document Control Specialist to join their team on a direct hire basis. 


Role and Responsibilities:

This is a leadership role in the control of quality records.  Origination of Engineering Changes and release of modified documents is a fundamental responsibility for this position.  Maintenance of all types of controlled documents, the Approved Supplier List, Equipment list, Global Regulatory standards and training records are all controlled through Portal’s online document management system Omnify. 


This person may be called upon to participate in the following areas. The right person for this position must have a willingness to learn.

  • Origination and Releasing of Engineering Change Notices
  • Maintenance of the Equipment items and calibration records
  • Maintenance of relevant Standards
  • Maintenance of Training records
  • All types of controlled documents and records will be managed in our online document management system
  • Running automated reports from Omnify
  • Compilation of quality metrics to support quarterly Management Reviews
  • Support for internal and external audits
  • Maintenance of Standard Operating Procedures, Work Instructions, forms and templates, among other document types.
  • Formatting of documents in Microsoft Word, Excel and Adobe Pro


Required Skills and Experience

  • Minimum of 5 years with hands on document control for medical devices, leadership positions a plus
  • Familiarity with automated document control systems, direct experience with Omnify a plus. 
  • Experience with Microsoft Word, Excel and Adobe Pro


Qualifications (Education, Experience, Skills):

  • Baccalaureate degree or equivalent work experience


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