Document Control Specialist

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.

• →Prepare, review, and circulate changes, including ECOs, DCOs, QCOs, and deviations in Arena PLM, typically originating from ECRs submitted by team members.
• →Manage Engineering Change processes from request through approval and implementation.
• →Release device firmware, drawings, components, documents, BOM files, and related product artifacts.
• →Work closely with the Detection and Analysis Manufacturing Engineering team on MCO activities, including work instruction creation and loader application setup before pilot builds.
• →Ensure all product artifacts are properly documented throughout the product lifecycle.
• →Maintain a document control system that meets applicable regulatory and quality system requirements.
• →Enter product BOMs into the PLM system and ensure the BOM files and documents are in the correct format and attached correctly into PLM and on required network drives for Manufacturing access.
• →Maintain accuracy, traceability, and accessibility of controlled files and supporting documentation.
• →Ensure changes flow correctly from Arena PLM to Oracle ERP.
• →Monitor and address issues identified on the BOM error report.
• →Review R&D team project Phase Gate artifacts according to ISO 9001 and ISO 13485 QMS requirements for completeness and accuracy.
• →Ensure projects are clear to move to the next project phase with complete, accurate, and audit-ready documentation.

• Bachelor’s degree in engineering, business, economics, life sciences, or a related field (or equivalent practical experience).
• Experience in document control, PLM, engineering support, quality, technical writing or a related role.
• Knowledge of engineering design processes and terminology.
• Understanding of document control systems, engineering change processes, and regulated product development environments.
• Knowledge of some PLM / CMS / ERP system. Arena preferred, not required.
• Very good spoken and written English. Communicative Czech language.
• Familiarity with ISO 9001 and ISO 13485 quality management system expectations is preferred.
• Ability to work independently and as part of a team.
• Excellent attention to detail and ability to manage multiple tasks simultaneously.
• Self-starter and pro-active approach.
• Strong communication, organization, follow-through, and prioritization skills.
• Eligible to work legally in the Czech republic.
• Occasional travelling can be required (less than 10%).