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 Software Validation Compliance Specialist II to become the newest member of our Quality Team located in Bothell, WA.
The Software Validation Compliance Specialist II is responsible for supporting cross-functional teams with planning, executing, and completing computerized system validation activities in compliance with the governing regulations. The responsibilities include configuration change management, validation and re-validation of systems supporting the Quality Management System (QMS).

Responsibilities:

• Ensure that the computerized systems and software are validated according to internal and external regulatory requirements
• Ensure that computerized systems validation requirements are effectively communicated to department management and system owners
• Collaborate with subject matter experts on projects
• Advise on the level of qualification and /or validation necessary to ensure compliance to all relevant regulations and industry guidance documents
• Prioritize system and software validation projects based on compliance risk and business needs
• Write and execute test scripts for systems and software
• Review, manage and execute computerized system configuration changes
• Develop and update validation, qualification, and configuration procedures for on premise and hosted (software as a service) computerized system
• Ensure that all documentation generated on projects adheres to Verathon change management processes
• Track and trend status on computerized system projects, and report on overall progress for validation activities
• Assess, audit and provide input on computerized system software suppliers
• Assist with maintenance of the electronic quality management system (MasterControl)
• Provide guidance and training on 21 CFR Part 11 and other applicable regulations on validation and maintenance of computerized systems
• 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:

• Bachelor’s degree in biomedical sciences, computerized systems or equivalent
• 2 years’ experience with computerized system validations; experience in an FDA-regulated environment preferred
• Familiarity with FDA, GMP, MDD, and ISO 13485 compliance, and working with GAMP 5 Model
• Experience with an electronic quality management system; MasterControl preferred
• Experience with performing internal systems and external software supplier assessments and audits
• Strong verbal and written communication skills
• Occasional travel to conduct computerized system supplier audits

• Ensure that the computerized systems and software are validated according to internal and external regulatory requirements
• Ensure that computerized systems validation requirements are effectively communicated to department management and system owners
• Collaborate with subject matter experts on projects
• Advise on the level of qualification and /or validation necessary to ensure compliance to all relevant regulations and industry guidance documents
• Prioritize system and software validation projects based on compliance risk and business needs
• Write and execute test scripts for systems and software
• Review, manage and execute computerized system configuration changes
• Develop and update validation, qualification, and configuration procedures for on premise and hosted (software as a service) computerized system
• Ensure that all documentation generated on projects adheres to Verathon change management processes
• Track and trend status on computerized system projects, and report on overall progress for validation activities
• Assess, audit and provide input on computerized system software suppliers
• Assist with maintenance of the electronic quality management system (MasterControl)
• Provide guidance and training on 21 CFR Part 11 and other applicable regulations on validation and maintenance of computerized systems
• 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