Document Control Specialist II Location US-Bothell ID 2024-1261 Category Quality Assurance/Regulatory Affairs Position Type Full-Time Work Model Onsite Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com. Overview Verathon is looking for a Document Control Specialist II to become the newest member of our Quality Assurance Team located in Bothell, WA. The Document Control Specialist II is responsible for supporting the Research and Development, Production, Quality Assurance and Regulatory Affairs, Operations and Marketing teams in preparation and organization of documents to ensure compliance with corporate document management procedures. The responsibilities include change management, document editing and preparation, document routing, and document release. This position also acts as an electronic Quality Management System (MasterControl) administrator for Verathon. Responsibilities * Follow all policies, procedures, and standards for documentation to ensure compliance with corporate document management procedures * Provide oversite and feedback in the creation, use and maintenance of organizational knowledge * Review generated documents to ensure they meet company standard formatting and numbering requirements * Review and edit procedural documents, including SOPs, work instructions and policies, for grammar, referencing and adherence to current procedures * Approve document and engineering change requests * Assist document structures, taxonomies, version control and routing in MasterControl * Release and archive documents maintained in MasterControl * Notify the organization of document and system changes * Work with cross-functional teams to enhance document management processes and procedures * Assign access rights and roles to users * Coordinate with Information Technology on identifying and troubleshooting MasterControl technical issues * Facilitate the creation and maintenance of MasterControl Organizers * Coordinate and facilitate training on MasterControl and document management procedures * Assign training for quality management system documents and manage training records * Receive and review records submissions and facilitate transfer to onsite or offsite storage * Facilitate the archival and final disposition of scanned and hardcopy records * Handle records checkout requests from onsite or offsite storage locations * Uphold the Verathon Company Mission and Culture Statement * Ensure consistent professional communications with all Verathon team members * Work on ad-hoc projects when required * Support Verathon's Quality Management System that establishes and maintains effective quality assurance processes and compliance to the International Standards: ISO13485, Canadian Medical Device Regulations (CMDR, SOR 98-292), FDA Quality System Regulations (QSR, 21 CFR Part 820) and the Medical Device Directive (MDD93/42/EEC) Qualifications * Minimum 1-2 years' experience required in Documentation