Staff Software Quality Engineer – Product Development

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.

Summary: The Staff Software Quality Engineer serves as a senior quality partner to software product development teams, providing technical leadership and oversight to ensure software products are developed in compliance with company quality requirements, applicable regulations, and industry standards. The role influences quality strategy and practices across complex product programs, mentors engineers, and partners with cross-functional teams to drive risk-based decision making, continuous improvement, and quality excellence in emerging technology areas, while remaining an individual contributor. Tasks and Responsibilities: Provide software quality leadership across multiple product development programs throughout the Software Development Life Cycle (SDLC) and Product Development Process (PDP).  Provide quality oversight and guidance for software development, verification, validation, cybersecurity, risk management, and product release activities.  Review and approve software lifecycle deliverables, including requirements, design documentation, traceability records, risk management documentation, verification and validation documentation, cybersecurity documentation, and software change records.  Lead resolution of complex software quality, compliance, and risk management challenges using a risk-based approach.  Influence key product development decisions by applying software quality engineering principles, regulatory expectations, and practical understanding of product risk.  Facilitate quality alignment across Software Development, Product Security, Regulatory Affairs, Product Management, and Program Management functions.  Drive consistency and improvements in software quality processes, tools, templates, and practices across product teams.  Lead or support software risk management activities throughout the product lifecycle.  Support complaint investigations, CAPA activities, audit observations, software nonconformances, and corrective action initiatives.  Provide quality guidance for cloud-enabled, cybersecurity-related, AI-enabled, and data-driven software solutions, as applicable.  Assess emerging technologies, development methodologies, and industry trends to identify quality and compliance improvement opportunities.  Develop and promote best practices, guidance materials, and reusable quality frameworks that improve organizational effectiveness.  Mentor and coach Software Quality Engineers and cross-functional stakeholders on software quality processes, regulatory expectations, and risk-based decision making.  Act as a trusted advisor within the Software Quality organization, helping shape future quality capabilities, operating practices, and organizational best practices.  Support internal and external audits and act as a subject matter expert for software quality-related topics.  Identify organizational risks, quality concerns, and process improvement opportunities, escalating as appropriate.  Contribute to strategic initiatives that strengthen software quality capabilities across the organization.  Support other areas of the Quality System and perform additional tasks as defined by management.  All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may