Document Control Specialist

General Summary

The Document Control Specialist is responsible for supporting document control within Novidan’s R&D process, manufacturing facility and supply chain. She or he will be responsible for managing the documentation system at Novidan.

Job Responsibilities

  • Responsible for documentation control at Novidan
  • Manage circulation of documents for review and approval
    • Own and enhance the training program for R&D
    • Drive the review and approval of engineering change requests (ECR)
    • Maintain and update documentation trackers
    • Clearly communicate overdue reviews, approvals, or closures to necessary parties
    • Manage meetings regarding training, documentation control, and engineering change requests
  • Support internal audits of the quality management system
  • Distribute updated documents to necessary parties, including suppliers and customers
  • Continually improve Novidan’s document control processes
  • Actively participate in the Material Review Board
  • Interface with key stakeholders on documentation status
  • Support and assist other areas, as needed

Job Requirements

  • Minimum: high school diploma or equivalent
  • Must have 3+ years of experience in a regulated product field
  • Experience with medical devices and ISO 13485:2016, a significant plus
  • Must be organized and have high attention to detail
  • Must have excellent writing skills
  • Advanced user of Microsoft products
  • Self-starter and resourceful

Working Environment

Normal office and light manufacturing conditions. Hybrid work flexibility available.


Little to no travel will be required.