Senior Software Quality Engineer

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Position Summary:  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  Assist in the development and delivery of training to employees on quality processes and practices  Provide support and guidance with new technologies development (e.g., AI/ML, Cybersecurity, Cloud, etc.) as it relates to software systems and tools  Support internal and external audits related to product software and software quality processes