Document Control Specialist


Summary: The Document Control Specialist role is a critical role within our Quality team and is responsible for assuring that quality documents and records are processed and controlled according to company approved procedures.

Essential Duties: 

  • Process (review, track, copy, scan, file, archive and maintain) quality documents and records in electronic and hardcopy format per relevant procedures.
  • Process change control orders.
  • Review, track, file and maintain employee training records.
  • Control engineering lab notebook distribution and retrieval.
  • Identify and implement improvements to the document control system.
  • Track external documents (e.g. ISO standards etc.) for completion of gaps analysis and update external document log
  • Train personnel regarding document format, content, use, control, and the document control system.
  • Audit quality records (e.g. device history records, equipment records) for completeness, accuracy, and conformance to appropriate SOP’s.
  • Collect and enter data into QA databases as needed.

Experience, Knowledge and Skills Required:

  • High School degree required.
  • Minimum five years related experience in the medical device industry.
  • Intermediate to advanced computer proficiency (MS Word, Excel, and Outlook)
  • Excellent communication and time management skills
  • Strong attention to detail required.
  • Administrative knowledge of Solidworks, Visio, and Adobe Acrobat preferred.

Interested candidates should submit their resume to humanresources@silkroadmed.com.

Join us!

  • AP140.A
    ©2018 Silk Road Medical

  • 735 North Pastoria Avenue,
    Sunnyvale, CA 94085

    phone: 855.410.TCAR (8227)
    local phone: 408.720.9002
    fax: 408.720.9013