Illumina · 6 hours ago
Software Quality Engineer 2
San Diego, CA
Full-time
Onsite
Mid Level
$73K/yr - $110K/yr
3+ years expIllumina is dedicated to expanding access to genomic technology for health equity globally. The Software Quality Engineer 2 will provide quality engineering support throughout the software development life cycle, ensuring compliance and validation of software for manufacturing processes.
BiotechnologyGeneticsHealth CareMedical
No H1B
Responsibilities
Provide ongoing software quality engineering support throughout the software development life cycle
Provide support to development, engineering and manufacturing functions for validation planning and transfer activities
Assist teams in determining verification and validation needs and requirements
Provide support for software development projects in the manufacturing areas by review/approval of software deliverables: Software Development Plans, Verification Plans, Validation Plans, User Requirements, Functional/Software Requirements, Configuration Specifications, Software Architectural and Design Documents, Peer Reviews, Risk Management Documents, Test Protocols, Requirement Traceability Matrices, Summary Reports
Provide review and approval of software related change orders
Ensure successful transfer of software from development into manufacturing product support
Participate in software the risk management process throughout the entire software lifecycle
Ensure compliance of validation efforts performed by internal/external validation personnel
Provide quality assurance support to software related CAPAs
Identify and make recommendations for improvements to the Software Quality Assurance Program
Assist in the development and delivery of training to employees on principles of software validation, software risk management, and general quality tools
Responsible for escalating potential risks to management
Responsible for exhibiting professional behavior with both internal/external business associates that reflect positively on the company and is consistent with the company’s policies and practices
Other such duties as may be determined by Management
Qualification
Required
3+ years Software Quality Engineering or relevant experience
Experience in a regulated environment, in vitro diagnostics/medical device
Experience and working knowledge of applicable regulations and standards: 21CFR 820, 21CFR Part 11, ISO 13485, IEC62304, ISO14971, GAMP5
Working knowledge of Software Development Life Cycle Models
Working knowledge of Software Configuration Management (SCM)
Experience with a variety of software categories desirable (e.g. COTS, Configurable, Custom)
Experience with software verification and validation
Experience with the application or risk management tools
Understanding of software development, inspection, and testing
Working knowledge of spreadsheets and word processor applications
Excellent attention to detail, strong organization skills, and ability to work independently and in teams
Excellent interpersonal, verbal and written communication skills
Ability to operate flexibly in fast-paced environment
Able to deliver quality outputs under minimal supervision
Experience with statistics, sampling plans, and statistical analysis
Typically requires a Bachelor's degree and a minimum of 3 years of related experience; or equivalent work experience
Preferred
Certified Software Quality Engineer preferred (e.g., CSQE)
Benefits
Access to genomics sequencing
Family planning
Health/dental/vision
Retirement benefits
Paid time off
Company
Illumina
Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.28BKey Investors
Bank of America
2024-09-06Post Ipo Debt· $500M
2023-01-04Post Ipo Debt· $750M
2000-07-28IPO
Leadership Team
Steven Barnard
Chief Technology Officer
Jenny Lei Zheng
SVP & GM of Greater China
Recent News
Genetic Engineering News
2025-12-24
Morningstar.com
2025-12-15
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