Software Quality Engineer 2 at Illumina

San Diego, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Genomics, HealthcareIndustries

Requirements

3+ years Software Quality Engineering or relevant experience
Certified Software Quality Engineer preferred (e.g., CSQE)
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 of 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

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 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

Skills

Key technologies and capabilities for this role

Software Quality AssuranceVerificationValidationSoftware Development LifecycleRisk ManagementRequirement TraceabilityTest ProtocolsCAPAChange OrdersPeer Reviews

Questions & Answers

Common questions about this position

What experience is required for the Software Quality Engineer 2 position?

Candidates need 3+ years of Software Quality Engineering or relevant experience, preferably with CSQE certification, and experience in regulated environments like in vitro diagnostics or medical devices.

What regulations and standards should I be familiar with for this role?

Familiarity with 21CFR 820, 21CFR Part 11, ISO 13485, IEC62304, ISO14971, and GAMP5 is required, along with working knowledge of Software Development Life Cycle Models and Software Configuration Management.

Is the salary specified for this Software Quality Engineer position?

This information is not specified in the job description.

What is the work arrangement or location policy for this role at Illumina?

This information is not specified in the job description.

What makes a strong candidate for this Software Quality Engineer role?

A strong candidate has 3+ years in software quality engineering, CSQE certification, experience in regulated medical device environments, and knowledge of key standards like IEC62304 and GAMP5, plus hands-on experience with software verification, validation, and lifecycle processes.

Illumina

Supports genomics startups through funding and resources

About Illumina

Illumina focuses on fostering innovation in the genomics industry by supporting startups through its Illumina Accelerator program. This program helps entrepreneurs create, launch, and grow genomics-focused companies by providing funding and resources. The accelerator operates in two main locations: the San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has successfully invested in 68 genomics startups, which have collectively raised over $1 billion in venture capital. What sets Illumina apart from its competitors is its strong partnership with leading venture capital investors and its dedicated focus on the genomics sector. The goal of Illumina is to build a thriving ecosystem for genomics innovation, enabling new companies to emerge and advance the field.

San Diego, CaliforniaHeadquarters

1998Year Founded

$27.2MTotal Funding

IPOCompany Stage

Venture Capital, BiotechnologyIndustries

5,001-10,000Employees

Risks

Over-reliance on NVIDIA's AI technology may limit flexibility in AI solution adoption.

Standardizing proteomics data across platforms could challenge Illumina's data reliability.

Single-flow-cell NovaSeq X System might cannibalize sales of higher-end models.

Differentiation

Illumina leads in genomic sequencing with advanced AI integration and multiomic data analysis.

The company offers innovative array-based solutions for DNA, RNA, and protein analysis.

Illumina's global expansion includes a new Global Capability Center in Bengaluru.

Upsides

Collaboration with NVIDIA enhances drug discovery and clinical development through AI integration.

Pilot proteomics program with UK Biobank aims to generate crucial reference datasets.

Single-cell sequencing kits make high-throughput sequencing accessible to smaller labs.

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