Senior Software Quality Engineer

About this role

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Skills you'll use

What you'll do

• 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.

Who can apply

• 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

About Illumina

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