Job description

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

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 and timely resolution

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 require reasonable accommodation for additional tasks and responsibilities.

Preferred Education:

Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline

Job Requirements:

5+ years’ experience in (software) quality engineering or related role in a regulated industry

Working knowledge of relevant industry standards and 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 to operate effectively 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, verbal and 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 be required

Willingness to work in shifts to support the US region (No night shift required)

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 [email protected]. 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.

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