US: SOFTWARE QUALITY ENGINEER
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SOFTWARE QUALITY ENGINEER
• Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan. Accuracy, clarity, consistency, completeness and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
* Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.
• Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 Corporate requirements as they relate to the development, verification, validation and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC software/firmware products.
• Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems.
• May Develop and maintain Validation Master Plan(s).
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
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Team SQAFYI - Software QA Resource FYI