US-CA-SantaClara: Software Regulatory QA Engineer
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Health Software Regulatory QA Engineer
The Health Software QA team is seeking a Regulatory QA Engineer to help us ensure that our Health related applications are high quality, user-focused, and in accordance with FDA and ISO regulations. Your duties will include understanding the most up to date system configurations, developing and updating test procedures and documentation, executing structured test passes and reports, and working multi-functionally with other involved quality teams.
Ability to investigate and debug difficult problems
Creative thinker and strong problem solver
An enthusiasm for user-focused design & high-quality technology
At ease and adaptable in a highly dynamic environment
Extensive experience in IEC 62304
Has experience with Software risk assessments
In this position you will need to be self-motivated with strong technical and social skills. You will handle responsibilities such as the functional testing of applications including Health, Heart, and Workout. Your responsibilities will include design and implementation of test plans and test cases, risk analysis, & integration testing across the system.
BS in Computer Science or equivalent on-the-job experience in software medical device quality industry.
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Team SQAFYI - Software QA Resource FYI