Senior Software Quality Assurance Engineer

2 weeks ago


Fremont, California, United States Blue Star Partners LLC Full time
Job Overview

Position Title: Senior Software Quality Assurance Engineer
Location: Remote
Contract Duration: 90-day contract with potential for extension
Work Hours: 40 hours per week, overtime compensated at time and a half
Compensation: $40 per hour
Employment Type: W2 Contract


Role Summary:

The Senior Software Quality Assurance Engineer will be responsible for ensuring that software products and computerized systems utilized in the Quality System are developed, validated, and maintained in accordance with both regulatory and corporate standards. This role involves active participation in project teams for products that integrate software and firmware into their systems. The engineer will review quality system documentation related to the development, verification, validation, and maintenance of software or firmware.


Key Responsibilities:

  • Execute Software Quality Assurance tasks in alignment with established Quality System Requirements.
  • Follow directives provided by the Software Quality Assurance Manager.
  • Evaluate predefined deliverables and activities as outlined in the Software Quality Assurance Non-Product Quality Process and/or Product Quality Process/project plan.
  • Ensure the accuracy, clarity, consistency, completeness, and compliance of documentation across multiple projects, including System Specifications, Verification Test Cases, Validation protocols, Trace Matrices, and Summary Reports.
  • Guarantee that computerized systems supporting the Quality System are developed, validated, and maintained in compliance with applicable regulations and corporate policies.
  • Confirm that deliverables and activities adhere to current Software/SWQA processes in the development of software and firmware products.
  • Report any unexpected events, issues, or software bugs encountered during verification and validation to the project team and management.
  • Possess a Bachelor’s degree or equivalent experience in a scientific, technical, or engineering field.
  • Have 5 to 8 years of experience in Software Quality Assurance.
  • Demonstrate knowledge of FDA Quality System Regulations, relevant ISO standards, and 21 CFR Part 11, with a particular focus on Design Control requirements.


Qualifications:

  • 2 to 4 years of project experience in software testing methodologies and practices, ideally in mobile applications.
  • Familiarity with tools such as Jira, Confluence, ALM Quality Center, or other software development and testing tools is advantageous.
  • ASQ Certifications are a plus.


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