Verathon is looking to solve the problem of ensuring compliance with governing regulations for computerized system validation activities, specifically in the areas of bladder volume measurement and airway management, by hiring a Software Validation Compliance Specialist III.
Requirements
- Familiarity with FDA, GMP, MDR, 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
- Knowledge of 21 CFR Part 11 and other applicable regulations on validation and maintenance of computerized systems
- Experience with computerized system validations; experience in an FDA-regulated environment preferred
- Strong understanding of computerized system validation requirements and regulations
- Experience with developing and updating validation, qualification, and configuration procedures
Responsibilities
- Manage computerized system validation projects from planning to release
- Ensure that the computerized systems and software are validated according to internal and external regulatory requirements
- 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
- Assess, audit and provide input on computerized system software suppliers
- 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)
Other
- Bachelor’s degree in biomedical sciences, computerized systems or equivalent
- 5 years’ experience with computerized system validations; experience in an FDA-regulated environment preferred
- Strong verbal and written communication skills
- Occasional travel to conduct computerized system supplier audits
- Ability to work in a team environment and provide guidance and training to others
