Software Quality Engineer
4 weeks ago
Job Title: Software Quality Engineer (Medical Devices)
Location:
Irvine CA
Duration:06 months (Possibility of extension)
Summary
The main function of this is to lead all software engineering activities relating to the validations of several production equipment with custom software. The main purpose of this role is to apply knowledge of software quality engineering to assess risk, execute validation activities and develop/approve software documents.
Job Responsibilities
Investigate complex product / non-product software quality and compliance issues (e.g. software deviations/failures) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects / systems / test equipment in partnership with cross-functional teams; provide recommendations for improvements.
Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.
Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.
Perform dry-runs and execution of Software Validation Protocols.
Train, coach, and guide other employees on software documentation.
Other Incidental duties as required.
Education/Experience
Bachelor’s degree in engineering with minimum of 5 years of experience, or Master's degree in Engineering with a minimum of 4 years of experience.
Previous experience with software verification and validation activities in a medical device industry.
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