Software Quality Engineer

Software Quality Engineer provides support to Illumina’s software development teamsto ensure product software is developed in compliance with Illumina’spolicies/procedures and applicable regulatory requirements (e.g., 21CFR820, QMSR)and International Standards (e.g., ISO 13485, IEC 62304).The role supports execution of software quality activities across assigned program(s),ensuring deliverables are completed on time and in compliance with establishedprocesses. The engineer works closely with cross-functional teams and contributes tocontinuous improvement of software quality practices.Tasks and Responsibilities:Provide software quality support across the Software Development Life Cycle (SDLC)for assigned program(s)● Collaborate with cross-functional teams (Software Development, ProgramManagement, Product Security, etc.) to support execution of quality activities● Provide support on software development projects through review and approvalof 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 needs and requirements● Participate in software risk management activities throughout the productlifecycle● Participate in design reviews to support effective development, transfer, andmaintenance of software products● Provide support for software-related quality issues (e.g., complaints, CAPA),including investigation and resolution activities● Identify opportunities for process improvements and support implementation ofcontinuous improvements in the Software Quality Program● Support development and delivery of training on software quality processes andpractices● Provide support for new technology areas (e.g., AI/ML, Cybersecurity, Cloud) asapplicable to software systems and tools● Support internal and external audits related to product software and softwarequality processes● Escalate risks and issues as appropriate to ensure timely visibility and resolution● Support other areas of the Quality System and perform additional tasks asdefined by managementAll listed tasks and responsibilities are deemed essential functions to this position;however, business conditions may require reasonable accommodation for additionaltasks and responsibilities.Preferred Education:● Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics,Biomedical or related disciplineJob Requirements:● 6+ years’ experience in (software) quality engineering or related role in aregulated industry● Working knowledge of applicable industry standards and regulations (e.g., IEC62304, ISO 13485, 21 CFR)● Basic understanding of software development lifecycle (SDLC) processes andsoftware engineering best practices● Ability to execute assigned quality tasks with guidance and direction● Experience working with cross-functional teams in a collaborative environment● Good interpersonal, verbal, and written communication skills● Ability to apply core Quality Engineering principles, including documentation andrisk management basics● Ability to work in a fast-paced and dynamic environment● Experience in a global delivery model preferred● Occasional travel may be required● Willingness to work in shifts to support the US region (No night shift required)

Pay: ₹1,500,000.00 - ₹1,700,000.00 per year

Application Question(s):

• Aware of IEC

62304 and ISO 13485?

• Hands on experience of SDLC, DHF,SAMD?

Work Location: Hybrid remote in Bengaluru, Karnataka 560100