Senior Software Quality Engineer

The Senior Software Quality Engineer provides support to Illumina s software development teams to ensure product software is developed in compliance with Illumina s policies/procedures and applicable regulatory requirements (e.g., 21 CFR 820, QMSR) and International Standards (e.g., ISO 13485, IEC 62304).

The Senior Software Quality Engineer is responsible for driving quality activities for assigned programs or projects, ensuring timely execution, compliance, and continuous improvement.

Tasks and Responsibilities:

• Serve as a subject matter expert (SME) in Software Quality Engineering and act as the primary quality partner for assigned projects
• Provide end-to-end software quality support across the software development life cycle (SDLC), with ownership of quality deliverables for assigned areas
• Collaborate with global cross-functional teams (Software Development, Program Management, Product Security, etc.) across time zones to ensure alignment and execution
• Review and approve development deliverables, including: Software Development Plans, Verification Plans, Validation Plans
• Product/Software Requirements
• Software Architectural and Design Documents
• Test Protocols, Requirement Traceability Matrix, Test Reports
• Cybersecurity and risk-related documentation
• Assist teams in determining verification and validation strategies, ensuring alignment with regulatory and quality requirements
• Participate in and drive software risk management activities throughout the product lifecycle
• Provide review and approval of software-related orders
• Participate in design reviews to ensure effective development, transfer, and maintenance of software products across the lifecycle
• Provide support for software related issues (Complaints, CAPA, etc.), including investigation, resolution, and identification of systemic improvements
• Identify and make recommendations for continuous improvement of the Software Quality Program

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