Senior Software Quality Engineer

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(e.g.,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.