Document Management & QA Support Coordinator
Core
Reviews and verifies engineering drawings, bills of material, and configuration management to ensure technical information is accurate, current, traceable, and properly controlled within the Quality function.
Role type
QA Support Coordinator (Configuration Management & Document Control)
Builds
Controlled engineering documentation, drawing releases, and configuration management artifacts for medical device and pharmaceutical clients.
Domain
Healthcare / Medical Devices / Manufacturing Quality Systems
Required skills
Engineering Technology or related discipline background, 3-5 years in configuration management, PDM systems proficiency, electronic document management systems experience, audit support, QMS metrics reporting, ISO 9001/13485 familiarity, MasterControl/Autodesk Vault experience, attention to detail, analytical problem-solving.
Preferred skills
Experience with ISO 13485, ISO/IEC 17025, CSA N299, conducting supplier audits, managing QMS databases.
Technologies
MasterControl, Autodesk Vault, Microsoft Word, Quality Management Systems, Product Data Management (PDM) systems.
Responsibilities
Review and verify engineering drawings and bills of material against quality requirements; manage creation, revision, approval, and distribution of controlled documents; support engineering change activities and new product introductions; troubleshoot document and configuration issues; maintain quality and regulatory records; support internal and supplier audits; prepare quality metrics and routine reports.
Seniority
Mid-level, hands-on IC