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Software Quality Assurance Engineer

2 months ago

Alameda, United States EPITEC Full time

Full-time, Contract, Epitec W2


Alameda, CA 94502


Software Quality Assurance Engineer


About the Role: Ensure that product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. Participates as a member of the project team for Abbott Lingo products that incorporate software/firmware into their system. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of the software or firmware.


Responsibilities:

  • Completes SWQA tasks in accordance with current Quality System Requirements.
  • Works according to objectives given by SWQA Manager.
  • Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
  • Ensure documentation accuracy, clarity, consistency, completeness and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports.
  • Ensures that Abbott and Lingo computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements.
  • Ensures that deliverables and activities are in compliance with current Software/SWQA processes in the development of Lingo software/firmware products.
  • Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.


Qualifications:

  • Bachelors degree, or equivalent experience, in a scientific, technical, or engineering discipline.
  • 5 to 8 years experience in Software Quality Assurance.
  • Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. In particular, has knowledge of Design Control requirements.
  • Must have 2 - 4 years project experience in software testing practices, methodologies and techniques, preferably in mobile applications.
  • Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools is a plus.
  • ASQ Certifications a plus


Pay range and compensation package: 38.01-40.00/hr