Document Control Specialist
Core
Maintain integrity, accuracy, and compliance of product documentation throughout the product lifecycle, managing Engineering Change processes and ensuring audit-ready documentation for regulated product development.
Role type
Document Control Specialist
Builds
Product artifacts, design records, firmware, drawings, BOMs, and supporting documentation for mission-critical applications in healthcare and advanced manufacturing.
Domain
Healthcare and advanced manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Document control, PLM systems, engineering change processes, regulated product development environments, BOM management, quality management system compliance
Preferred skills
ISO 9001 and ISO 13485 knowledge, Arena PLM experience, technical writing
Technologies
Arena PLM, Oracle ERP
Responsibilities
Prepare, review, and circulate changes including ECOs, DCOs, QCOs, and deviations in Arena PLM; Manage Engineering Change processes from request through approval and implementation; Release device firmware, drawings, components, documents, BOM files, and related product artifacts; Work with Manufacturing Engineering on MCO activities including work instruction creation; Maintain a document control system meeting regulatory and quality system requirements; Enter product BOMs into the PLM system and ensure correct formatting and attachment; Review R&D team project Phase Gate artifacts for completeness and accuracy according to ISO standards; Ensure changes flow correctly from Arena PLM to Oracle ERP.
Seniority
Individual Contributor