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
The Senior Software Quality Engineer providessupportto Illumina’s software development teams to ensureproduct software is developedin compliance withIllumina’s policies/procedures and applicableregulatory requirements (e.g.,21CFR820,QMSR)andInternational Standards (e.g.,ISO 13485, IEC 62304)
The Senior Software Quality Engineeris responsible fordriving quality activities for assigned programs orprojects, ensuringtimelyexecution, compliance, and continuous improvement.
TasksandResponsibilities:
Serve asa subject matter expert(SME)inSoftware Quality Engineering andact as the primary quality partnerfor assigned projects
Provideend-to-endsoftware quality supportacrossthe 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
Cybersecurityand risk-related documentation
Assistteams indeterminingverification 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 supportforsoftware related issues (Complaints, CAPA, etc.),including investigation, resolution, and identification of systemic improvements
Identifyand make recommendations forcontinuousimprovementofthe Software Quality Program
Assistin the development and delivery of training to employees onquality processesand practices
Provide support and guidance withnew technologiesdevelopment (e.g., AI/ML, Cybersecurity, Cloud, etc.)as it relates to software systems and tools
Support internal and external audits related to productsoftwareand software quality processes
Contribute to building and scaling Software Quality Engineering capability within the India team, including standardization of processes and best practices
Escalate potential risks and issues to management proactively to ensure visibility andtimelyresolution
Support other areas of the Quality System and performadditionaltasks as defined by management
All listed tasks and responsibilities aredeemedessential functions to this position; however, business conditions may require reasonableaccommodationforadditionaltasksand responsibilities.
PreferredEducation:
Bachelor’s degree inComputerScience, Software Engineering,Bioinformatics, Biomedical or related discipline
JobRequirements
5+ years’ experience in (software) quality engineering or related role in aregulated industry
Workingknowledgeofrelevant industry standardsand regulations(eg,IEC 62304,ISO 13485, 21 CFR)
Strong understanding of software development lifecycle (SDLC) processes and software engineering best practices
Experience working in a global delivery model with cross-functional teams across geographies preferred
Ability to independently own and execute quality activities for assigned programs with minimal supervision
Ability tooperateeffectively in a fast-paced and dynamic environment
Strong collaboration skills with cross-functional teams (Software Development, Program Management, Product Security, etc.) to drive a culture of quality
Good interpersonal,verbaland written communication skills
Ability to apply Quality Engineering principles effectively, including structured development processes and risk management
Quality and/or Regulatory Certifications (ASQ,AAMI,RAPS,etc.)preferred
Experience mentoring or guiding junior engineers preferred
Occasional travel may berequired
Willingness to work in shifts to support the US region (No night shiftrequired)
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
At Illumina, our goal is to apply innovative technologies and revolutionary assays to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service. As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative, array-based solutions for DNA, RNA, and protein analysis serve as tools for disease research, drug development, and the development of molecular tests in the clinic.
