US-CA-Carlsbad: Senior Software Quality Engineer
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Senior Software Quality Engineer
SUMMARY OF POSITION: Responsible for ensuring that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to division manufacturing plants for computerized system validation.
ESSENTIAL FUNCTIONS: 1. Promote a structured software development process. Assure that a state of control is maintained for in-house and outsourced software development. 2. Participate in critical analysis, design, and change review meetings for product and non-product software. 3. Provide oversight of manufacturing software validation process. 4. Generate metrics for assessing software quality and evaluate results. 5. Contribute to process improvements by developing and/or updating written company or departmental procedures related to software development. 6. Provide oversight during software release to manufacturing as well internal distribution. 7. Administer and control problem-tracking database and oversee defect process resolution. 8. Support outsourced software vendor audits and qualification. 9. Provide software validation, design controls, and risk management training. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS: Education: • Bachelor of Science degree in Electrical Engineering, Computer Science, or Computer Engineering
Experience: • 5+ years in software test or software quality engineering role
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Team SQAFYI - Software QA Resource FYI