US: SQA ENGINEER - MEDICAL DEVICES
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please visit http://sqa.fyicenter.com
SQA ENGINEER - MEDICAL DEVICES
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.
1. BS in Computer Science or related field with 5 years of related experience.
2. 5+ years as a Software QA professional in an FDA regulated setting
3. Experience testing firmware/ software on complex laboratory instruments containing motors, pumps, robotic arms, etc.
4. Thorough knowledge of Software QA process and documentation in a medical device software development environment
5. Ability to work independently and in a team environment
6. Excellent oral and written communication skills; Able to communicate well with both technical and non-technical people.
7. Able to work on multiple projects simultaneously
8. Experience with a version control system (i.e. CVS), Defect-tracking and automated testing tools.
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Team SQAFYI - Software QA Resource FYI