Document Control Specialist
Core
Manage and organize quality documentation for cGMP compliance, issuing and controlling documents for device development and manufacturing.
Role type
Document Control Specialist
Builds
Controlled documentation, device master records, BOMs, and routes for medical device product realization
Domain
Medical device manufacturing / Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
document control, data entry, database searching, data analysis, Microsoft Word, Microsoft Excel, planning software, regulatory compliance knowledge
Preferred skills
training development, process improvement, system troubleshooting
Technologies
AX, Net Dimensions, product information management systems
Responsibilities
Issue quality system documents and coordinate training; process document change orders; create and update BOMs and routes; monitor transactions in AX; troubleshoot AX issues; assist in new item creation and system setup
Seniority
Entry-level to Mid-level, hands-on IC