The Software Quality Assurance Engineer is responsible for creating, implementing and automating testing in support of software test requirements. The SQA Engineer develops and expands test suites and test cases, and maintains the automation infrastructure. In addition, the SQA Engineer will execute and report on planned tests, report and manage defects, regress software fixes for new and existing products, assist development with replicating and debugging problems and develop new test automation solutions as needed.
In this role, you will create and work with team in developing an overall testing strategy, including phases of testing to be conducted, roles and responsibilities, test data, environments and user acceptance testing.
Provide insight and individual contribution in obtaining and maintaining compliance with ICH Q7 guidance for active pharmaceutical ingredients. Troubleshoot method and process issues in assurance of successful validation. Recommend technical design/changes to improve efficiency, quality or performance in support of validation.
Reviews each client medical records regarding admission HIS documentation, accurate and timely documentation of eligibility criteria, and review of clinical documentation to ensure minimum standards addressed and initial orders are complete.
Work with the DCHU and Support teams to ensure the compliance of the complaint handling program to ensure complaints are identified, processed, and investigated per internal procedures and regulatory requirements.