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.
Key Skills for This Role
AI/MLCloudCybersecurity
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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
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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 practice s
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 C omputer S cience , 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 qualit y
Good interpersonal, verbal and written communication skills
Ability to apply Quality Engineering principles effectively, including structured development processes and risk management