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.

Travel

Little to no travel will be required.