Software Quality Engineer

Sunnyvale, CA 94089

Posted: 05/14/2019 Industry: Software Engineer Job Number: 8722 Pay Rate: Not Specified
As a Software Quality Engineer, you will be responsible responsible for the creation, submission, execution, and review of software test protocols in the Software Quality department. Contribute to the completion of milestones associated with specific projects or activities within software quality department. Applies analytical skills and independent judgement in resolving software issues in coordination with software engineers. SQA Engineers are responsible for the quality of the software that is shipped to customers, used in manufacture of medical devices, used in the companies quality system, and system software that is used throughout the company.

Essential Job Responsibilities:
* Performs duties as an individual contributor and/or team member with 100% hands-on work.
* Creates test plans, reports, and OQ, PQ test protocols
* Review related software documents such as requirements and develops test cases
* Collaborate with appropriate departments to review validation documentation
* Represents core team in project meetings
* Coordinate traceability matrix updates and contribute to regulatory submission documents
* Reviews executed test protocols and approves issue resolutions
* Must have a minimum of 3 years of software validation experience in regulated industry * Must have experience in writing OQ and PQ test protocols * Experience with other applications such as defect tracking, web-based applications, requirements management * Must have strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction * Must be able to lift instruments up to 20 pound *Must have a degree in Bioengineering, Biomedical, or Electrical Engineering Nice to have: * Has worked in a regulated environment and have experience with 21 CFR Part 11 regulations * Experience with AWS/Cloud testing
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