Software Quality Assurance Engineer

Position: Software Quality Assurance Engineer

Preferred Bayarea 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