The Software Quality Engineer will be responsible for participating in the verification and validation of Cepheid's software applications. This Software Quality Engineer will be primarily responsible for the quality of Cepheid's non-product software used in manufacture of medical devices and quality systems. Secondary responsibilities may include verification and validation activities for product software shipped to customers or system software used throughout the company.
- Successful candidate will perform duties as an individual contributor and/or team member with 100% hands-on work.
- Participate in requirements development, protocol development, risk analysis, configuration and change control, and design reviews.
- Plan, schedule, write, and execute software test documentation.
- Record, report, and track defects to accurately depict the status of the software projects.
- Work closely with Software and Manufacturing Engineering staff toward the reporting and resolution of design issues and/or software defects.
- BA/BS degree in Computer Science or related field.
- A minimum of 5 years of software testing experience is required in a FDA regulated environment.
- The candidate must have completed several major projects with multiple release cycles and have working knowledge of software development lifecycle in a regulated field.
- Must have experience with: Windows environments, Excel macros and/or complex spreadsheets, and SQL or other RDBMS systems.
- Should have extensive knowledge in mathematics specific to differential equations and integration. Study of Calculus at undergraduate level is a must.
- Should have experience in all aspects of software testing: developing test plans, traceability matrixes, design of test cases, test protocols, test data and composition of validation reports.
- Must possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products quickly.
- Must have strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction.
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