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Dice is the leading career destination for tech experts at every stage of their careers. Our client, Akshaya Inc, is seeking the following. Apply via Dice today! Position: CSV-QA / SQA Engineer Location: Preferred Bay area candidate Hybrid But open for REMOTE ONLY for 100% skill matching candidates Position Summary: • Sr CSV-QA / SQA Engineer will work with the Natera Software Engineering team to ensure appropriate • software validation & lifecycle documentation is in place to support changes to Laboratory and Product • software systems. This role will provide value-added guidance throughout the software development lifecycle process. Primary 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. Qualifications: • 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