Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
How will you make an impact?
As part of the fast-growing team in Genetic Testing Solutions, you will ensure the integrity, accuracy, and design compliance of software testing in an FDA regulated environment. You will be involved with quality and test advocacy, test resource planning and management, and resolution of issues that impede the testing effort. Coordination of software testing activities will ensure software is fit for intended use, mitigates all identified risks, and is free of unexpected anomalies.
What will you do?
• Define the scope of testing within the context of each software release
• Plan, deploy and manage the testing activities for any given engagement
• Estimate the testing effort and collaborate with management to acquire the necessary resources.
• Author, review, and approve verification protocols, reports, and trace matrices, ensuring design compliance, test coverage, and suitability of protocols for clinical laboratory software
• Determine the appropriate test measurements and metrics for the product
• Drive improvement in test methodologies and technologies for test automation, reporting, traceability, and defect management
• Ensure software verification and validation activities are in accordance with FDA guidance on testing and validation, design compliance with internal procedures, and to ensure suitability to intended use of the clinical product
• Ensure test toolsets are properly maintained, validated, and documented according to FDA guidance on Validation, and that the test environment is in place prior to test execution
• Participate in Software Hazard Analysis activities to ensure a full understanding of patient and safety risks for our clinical software products, and ensure that risk control measures are implemented correctly and tested accordingly
• Collaborate with algorithm engineers to develop algorithm test plans and unit testing protocols.