The Document Control Specialist is responsible for maintaining the integrity, accuracy, and compliance of product documentation throughout the product lifecycle. Working closely with Engineering, Manufacturing Engineering, Operations, Quality, and Regulatory Affairs, this role ensures that all product artifacts, design records, firmware, drawings, bills of materials (BOMs), and supporting documentation are properly controlled, reviewed, released, and maintained in accordance with quality system and regulatory requirements.
The role manages Engineering Change processes from request through approval and implementation, including the preparation, review, and coordination of Engineering Change Requests (ECRs), Engineering Change Orders (ECOs), Document Change Orders (DCOs), Quality Change Orders (QCOs), manufacturing change activities, and deviations within Arena Product Lifecycle Management (PLM). This position partners closely with Manufacturing Engineering to support pilot builds, work instruction development, and production readiness activities.
The Document Control Specialist is also responsible for ensuring documentation accuracy and accessibility by maintaining correct BOM structures, controlling document releases, and verifying that product data is properly transferred between Arena PLM and Oracle ERP systems. Additionally, this person performs quality reviews of R&D Project deliverables to ensure compliance with ISO 9001 and ISO 13485 quality management system requirements, enabling projects to progress through the development lifecycle with complete, accurate, and audit-ready documentation.