Senior Software Quality Engineer

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: Senior Software Quality Engineer

Location: Bengaluru, India

Function: Software Quality Engineering

Reporting to: Senior Manager - Quality

Job Type: Hybrid

Position Summary:

The Senior Software Quality Engineer serves as a key quality partner to software product development teams, ensuring software products are developed in compliance with company quality requirements, applicable regulations, and industry standards.

This role supports and executes software quality activities throughout the software development lifecycle, partnering with cross-functional teams to drive quality, risk management, and compliance across a diverse portfolio of software products and technologies.

Tasks and Responsibilities:

• Support software quality activities for product development programs throughout the Software Development Life Cycle (SDLC) and Product Development Process (PDP).
• Serve as the primary quality representative on assigned cross-functional product teams.
• Provide quality oversight and guidance for software development, verification, validation, and risk management activities.
• Review and approve software lifecycle deliverables, including requirements, design documentation, test documentation, traceability, cybersecurity, and risk management records.
• Partner with Software Development, Program Management, Regulatory Affairs, Product Security, and Product Management teams.
• Provide guidance on software quality processes and quality system requirements.
• Participate in design reviews and key product development activities.
• Support complaint investigations, CAPA activities, nonconformances, and corrective actions.
• Review and approve software-related changes and quality deliverables.
• Support software quality activities across multiple products, platforms, and technologies.
• Provide quality guidance for solutions utilizing cloud-based platforms, cybersecurity features, and AI-enabled capabilities, as applicable.
• Identify opportunities to improve software quality processes, tools, and practices.
• Support internal and external audits.
• Deliver training and share software quality best practices.
• Contribute to continuous improvement initiatives within the Software Quality organization.
• Escalate quality risks and issues as appropriate.
• 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…