Software Quality Assurance Engineer III

Job Title : Software Quality Assurance Engineer III

Location : Alameda, CA – Onsite – local candidates only

Period : 90 day contract – potential for extension

Hours / Week : 40 hours – hours over 40 will be paid at time and a half

Rate : $40 / hr

Contract Type : W2 only

Scope of Services :

The Software Quality Assurance Engineer III will 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 Company 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. Coordinate activities with other team members and other functions.

Role, Responsibilities, and Deliverables :

• 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 Company 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.
• 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.

Education & Experience :