Document Control Specialist 3 - Evening Shift
Core
Manage the change control system, review and release change orders, and maintain quality documents and records in compliance with ISO 13485 and 21 CFR Part 820.
Role type
Senior Document Control Specialist
Builds
Quality management systems and controlled documentation for medical device manufacturing
Domain
Medical Devices / Quality Assurance
Required skills
Change control management, document lifecycle management, audit support, electronic documentation systems, Microsoft Office Suite, regulatory compliance (ISO 13485, 21 CFR Part 820), GDP/GMP knowledge
Preferred skills
Problem-solving, critical thinking, report generation
Technologies
Electronic documentation systems, Microsoft Office Suite, Change control software
Responsibilities
Manage the change control system and route change orders, Ensure projects are completed accurately and on time, Support Quality in internal and external audits, Scan, archive, retrieve, and issue controlled documents, Generate Quality Assurance reports, Monitor status of in-process document changes
Seniority
Mid-Senior, hands-on IC
