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.
Skills Required
- 5+ years' experience in software quality engineering or related role in a regulated industry
- Working knowledge of IEC 62304, ISO 13485, 21 CFR (medical device software standards and regulations)
- Strong understanding of software development lifecycle (SDLC) processes and software engineering best practices
- Ability to independently own and execute quality activities for assigned programs with minimal supervision
- Ability to apply Quality Engineering principles effectively, including structured development processes and risk management
- Strong collaboration skills with cross-functional global teams (Software Development, Program Management, Product Security)
- Good interpersonal, verbal and written communication skills
- Willingness to work in shifts to support the US region
- Bachelor's degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline
- Experience working in a global delivery model with cross-functional teams across geographies
- Quality and/or Regulatory Certifications (ASQ, AAMI, RAPS, etc.)
- Experience mentoring or guiding junior engineers
Illumina Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Illumina and has not been reviewed or approved by Illumina.
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Healthcare Strength — Health coverage includes comprehensive medical (HMO/PPO), dental, vision, mental health, life, and disability insurance with options such as FSAs/HSAs and wellness resources. Offerings are described as robust across regions with customization in certain locations.
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Leave & Time Off Breadth — Time-off programs include flexible schedules and remote work, PTO or flexible time off, paid holidays and sick leave, and volunteer time. Company-wide shutdowns during summer and winter add additional paid time away.
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Parental & Family Support — Family-focused programs include fertility assistance, adoption assistance, and reproductive health support alongside family medical leave. Paid parental leave is provided, with specifics varying by country and employment status.
Illumina Insights
What We Do
Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.
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