Senior Software Quality Engineer
Role Overview
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.
Key Skills for This Role
Full Job Posting
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)
Qualifications
- Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline
- 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)
About Illumina
Global leader in DNA sequencing and genomic technologies.
Visit company websiteJobs and hiring trendsApply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Illumina
Senior Territory Account Manager
, USA
Sr Systems Test Engineer
, USA
Senior Manager, Design Quality
, USA
Apprentice(Finance)
Bengaluru, IND
Sr Staff, NPI Sourcing Manager
, USA
Material Coordinator 3
, USA
Senior Bioinformatics Engineer
, USA
Electrical Engineer 2
, USA