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