Senior Software Quality Assurance Engineer (SQE)

Automated Testing: Develop, implement, and maintain test scripts using appropriate tools to automate testing and regression testing for validated systems, increasing efficiency and repeatability. 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). Participate in internal and external audits (e.g., ISO, regulatory body inspections) as the CSV expert. 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.