This position is responsible for implementing best practices and company policies for software quality assurance directly contributing to quality deliverables for Terumo CVS software and services. The role will include, but is not limited to: (1) planning and executing System Development Life Cycle activities per the established Quality Management System methodologies, (2) reviewing and approving various Software Development Life Cycle deliverables, change control, and resulting Objective Evidence to ensure adherence to the established company policies and regulatory requirements, and (3) working with stakeholders and members of designated project teams to ensure that computerized systems that are used in support of regulated activities and/or business processes, work as intended. 1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 2. Enforce the applicable business, technical, regulatory, and procedural requirements for software implementations. 3. Enforce the company’s Quality Standards and Procedures for Computerized Systems, as defined in Terumo CVS’s governing Quality Management System. 4. Participate in the validation of Computerized Systems such as, but not limited to, Enterprise Software, Crystal Reports, Automated Equipment, Regulated Spreadsheets, Medical Device Test Fixtures, and R&D Systems. 5. Help implement risk-based System Validation, Process Validation and Software Validation. 6. Provide interpretation and guidance on various SDLC methodologies. 7. Participate in department quality improvement initiatives and actively apply software QA methodology standards. 8. Actively lead and/or directly support QA initiatives for planned and unplanned software releases. 9. Create, maintain, summarize, review, and approve QA related-documentation against quality-document attributes, including but not limited to good documentation practices, completeness, traceability, accuracy, coverage and testability of system requirements, software defect detection, compliance risk mitigation, change management, roles and responsibilities. 10. Report on QA activities including, but not limited to process and system compliance metrics. 11. Collaborate with Product and project management teams on system-related enhancements as well as issue resolution. 12. Review business and technical designs, mock-ups, and other work products for new functionality/features and provide feedback as needed. 13. Demonstrate a broad knowledge of business system architectures, including but not limited to: Web, Mainframe, Client-Server, Mobile, and Software-as-Service. 14. Proactively escalate issues and risks appropriately through proper channels. 15. Perform other duties as assigned.
