Job Title: Software Quality Assurance Engineer
Location: Alameda, CA 95054
Duration: 6+ months (Strong possibility for extension)
Job Description / Requirement:
Primary Function / Primary Goals / Objectives:
• Ensure that SWQA computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements
• Plan, design, develop and execute tests to ensure the highest possible software quality for ADC products.
• Coordinate SWQA activities with other engineering disciplines, departments and contractors.
• Estimate, plan and review own and others’ work products.
• Completes SWQA tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Manager.
• Can plan and coordinate own work according to higher-level project schedules.
• Apply latest technical developments in Software QA discipline and provide discipline guidance to project teams.
• As SWQA Lead, may coordinate and/or direct activities of other SWQA engineers working on a project.
• Review SWQA and peer's documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects.
• Including System Specifications/Requirements documents, Validation protocols, Trace Matrices and Validation Summary Reports for the Alameda site.
• Report unexpected events, issues or software bugs which occur during validation to project team and management.
• Assist SWQA team members in meeting their goals by providing coaching and mentoring as needed.
• Maintain schedule and drive to meet SWQA schedule as aligned with project(s) goals.
• Ensure that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems.
• Develop and maintain Validation Master Plan(s)
• Develop and maintain department operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines , including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems used in the Quality System.
• May participate as Software Auditor for internal or external audits, provide software audit checklist and report on results of audit to Lead Auditor.
• Develop and execute Discovery and Verification Test Plans and Protocols.
• Test incremental builds, log bugs in the bug tracking system and report issues to the development team.
• Minimum Education Required: MS preferred, holds a Bachelors degree, or equivalent experience, in a scientific, technical, or engineering discipline, with 5 to 8 years experience in Software Quality Assurance.
Minimum Experience/Training Required:
• Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. In particular, has knowledge of Design Control requirements.
• Has project experience in software testing practices, methodologies and techniques, particularly in testing medical devices.
• Experience leading test engineer team is a plus.
• Must have excellent oral and written communication skills.
• Knowledge of DOORs application is a plus.
• Accountability / Scope: Ensure that SWQA computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements.
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