Software Quality Assurance Engineer

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Akshaya Inc, is seeking a Senior Software Quality Assurance Engineer to work with the Natera Software Engineering team, ensuring software validation and lifecycle documentation support for laboratory and product software systems.

Responsibilities:

• Provide risk-based software validation guidance throughout the CSV process for custom and COTS software following GAMP 5, FDA 21 CFR part 11, Part 820, Annex 11 and GxP requirements
• Represent software QA on development projects. Perform risk assessments at system and functional levels for computerized systems
• CSV documentation review/approvals including Validation Plan, URS, FS, Design Specifications, System & Functional Risk Assessment, IQ/OQ/PQ Protocol & Report, Trace Matrix, and Validation Summary Report
• Review & approvals of changes and maintenance release Reports, tickets, change/release-based requirements/specs, TM, test cases/results
• Experience with Computer Software Assurance (CSA)
• Review & update procedures, requirements & specifications to ensure coverage of functional, configuration, design, part 11 (audit trails, eSig, access controls, etc.) and security requirements
• Provide guidance and support test execution based on risk and to ensure requirements, including intended use and part 11, are tested
• Ensure validation state of software systems is maintained
• Act as subject matter expert for CSV compliance and regulatory requirements related to CSV while working with cross functional stakeholders
• Experience and/or good knowledge of AI systems validation

Requirements:

• BS Degree in Computer Science or similar discipline; or equivalent work experience
• 12+ years of experience as a dedicated CSV analyst/lead in validation of cloud-based COTS configured and customized software applications
• Experience working in a CLIA Laboratory environment and/or FDA regulated environment
• Bayarea Candidate Hybrid
• REMOTE ONLY for 100% skill matching candidates
• Experience and/or good knowledge of AI systems validation