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| Category | Quality Assurance/Regulatory Affairs | Position Type | Full-Time | Work Model | Onsite |
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.
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.
* 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)
* Minimum 1-2 years' experience required in Documentation Management; experience with engineering and production environments preferred
* Diploma required; Bachelor's degree preferred
* Well-organized and detail oriented
* Excellent interpersonal communication skills
* Familiar with smart numbering conventions and revision control technique
* Experience in Microsoft Office products, especially with formatting Word documents
* Experience in Adobe Acrobat Pro
* Experience in document management tools and systems; MasterControl preferred
* Excellent interpersonal communication skills, including the ability to write clearly and concisely
If you're currently reading this and hesitating to click "Apply" because you don't check all the boxes, we encourage you to go for it! A true passion and excitement for making an impact is just as important to us as work experience.
Salary range - $22.56 - $30.64 per hour (Compensation will vary based on skills, experience and location. If this position is filled outside the Seattle WA metro area, this salary range will vary depending on the specific hiring location.)
Full-time non-sales employees are eligible for Verathon's annual bonus plan based on company and individual performance.
Verathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan. For more information, please visit our complete Benefits Summary at https://www.verathon.com/US-HQ-Employee-Benefits-Summary.
Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Verathon will be based on merit, qualifications, and abilities. Verathon does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.