1. Test software products for stability, usability, precision, accuracy, and reliability. Formulate and maintain test strategies; creating test plans and test cases for regression and functional testing of software products.
2. Work directly with the project team members, including software engineers, during key points along the software development process. Utilize the principals of the software development life cycle throughout the entire QA process.
3. Participate in product meetings throughout the development process to help guide the delivery of a quality product.
4. Utilize project planning and monitoring methods to ensure timely project completion.
5. Report problems via the defect tracking system Analyze, research, and track software defects through their resolution. Verify code fixes and sign off on resolutions.
6. Analyze test results and prepare SQA summary reports.
7. Establish and improve the SQA process/procedures.
8. Identify and recommend Software Quality Assurance testing tools and required equipment to; develop software test suites, implement automated test cases with a focus on functionality, performance, code coverage and regression testing; report software problems, verify fixes and review user documentation.
9. Ensure that software used in the development and manufacturing of medical devices is in accordance with 13485, the QSR, and the KMC Quality Procedures.
10. Mentor less experienced members of the Software QA team.