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.
- 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
- 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
Normal office and light manufacturing conditions. Hybrid work flexibility available.
Little to no travel will be required.