Software Quality Engineer 2

Position Summary

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., 21CFR820, QMSR) and International Standards (e.g., ISO 13485, IEC 62304).

The role supports execution of software quality activities across assigned program(s), ensuring deliverables are completed on time and in compliance with established processes. The engineer works closely with cross-functional teams and contributes to continuous improvement of software quality practices.

Tasks and Responsibilities

• Provide software quality support across the Software Development Life Cycle (SDLC) for assigned program(s)
• Collaborate with cross-functional teams (Software Development, Program Management, Product Security, etc.) to support execution of quality activities
• Provide support on software development projects through review and approval of 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 needs and requirements
• Participate in software risk management activities throughout the product lifecycle
• Participate in design reviews to support effective development, transfer, and maintenance of software products
• Provide support for software-related quality issues (e.g., complaints, CAPA), including investigation and resolution activities
• Identify opportunities for process improvements and support implementation of continuous improvements in the Software Quality Program
• Support development and delivery of training on software quality processes and practices
• Provide support for new technology areas (e.g., AI/ML, Cybersecurity, Cloud) as applicable to software systems and tools
• Support internal and external audits related to product software and software quality processes
• Escalate risks and issues as appropriate to ensure timely visibility and resolution

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.