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