Document Control Specialist

This role manages document workflows within an electronic document control system, overseeing the creation, revision, approval, and release of controlled documents. The position involves supporting change orders, maintaining quality records, and ensuring compliance with regulatory standards such as 21 CFR Part 820/QMSR and ISO 13485. The specialist also facilitates training programs, supports audits, and provides ancillary QA support for device history and nonconformance reviews.