Senior Software Quality Assurance Engineer (SQE)

10x Genomics-posted 11 days ago

Full-time • Mid Level

Pleasanton, CA

1,001-5,000 employees

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We are seeking a highly experienced and efficient Senior Software Quality Assurance (SQE) Engineer to join our Quality team. This critical role focuses on the validation and compliance of non-product, business-critical computerized systems in our regulated environment. The ideal candidate will have deep expertise in Computer System Validation (CSV) within design-controlled industries, ISO 9001 and ISO 13485 with a strong drive to automate all manual processes for increased effectiveness and reliability.

Automated Testing: Develop, implement, and maintain test scripts using appropriate tools to automate testing and regression testing for validated systems, increasing efficiency and repeatability. Utilize agentic AI and LLM’s to design and develop tools that increase process efficiency
Computer System Validation (CSV): Lead and execute all activities related to the validation lifecycle of non-product software systems, ensuring compliance with internal procedures, ISO 13485 (future state), and relevant regulatory requirements.
System Validation Expertise: Act as the subject matter expert for the validation of essential corporate systems, which may include: Enterprise Resource Planning (ERP) Systems (i.e. Salesforce, Oracle). Production software (LIMS, eQMS etc.). Spreadsheet Validation (e.g., Microsoft Excel) used for critical manufacturing and quality control processes.
Process Documentation: Author, review, and approve validation documentation, including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Traceability Matrices (TM), Test Protocols (IQ/OQ/PQ), and Validation Reports (VR).
Compliance & Audits: Ensure all validation activities and system documentation are maintained in an "audit-ready" state. Participate in internal and external audits (e.g., ISO, regulatory body inspections) as the CSV expert.
Change Control: Manage validation efforts related to system updates, patches, configurations, and major upgrades through the established Change Control process.

Technical Skills: Proficiency in writing automation scripts in Python and using software testing tools to drive efficient, repeatable testing.
Experience: 5 years of experience in Software Quality Assurance AND Computer System Validation (CSV) in a regulated, design-controlled industry (e.g., Medical Devices, Pharmaceuticals, Biotechnology).
Regulatory Knowledge: Demonstrated, in-depth understanding of ISO 13485 (or strong experience with an equivalent quality standard like FDA 21 CFR Part 820 or 21 CFR Part 11). Current experience in an ISO 9001 environment is a plus.
Documentation Skills: Exceptional technical writing skills with the ability to create clear, concise, and compliant validation documentation.
Education: Bachelor's degree in Computer Science, Engineering or a related technical field.

Hands-on experience with Agentic AI and LLM
Basic understanding of GxP or FDA 21 CFR Part 11
System Proficiency: Proven, hands-on experience validating commercial off-the-shelf (COTS) and configured software, specifically ERP systems (e.g., SAP, Oracle, NetSuite, etc.), LIMS, and complex spreadsheet validation.

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