Description

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 Summary:

Software Quality Engineer 2 provides support to Illumina’s software development teams to ensure product software is developed in compliance with Illumina’s policies/procedures and applicable regulatory requirements (e.g., 21CFR820, QMSR) and International Standards (e.g., ISO 13485, IEC 62304).

The role supports execution of software quality activities across assigned program(s), ensuring deliverables are completed on time and in compliance with established processes. The engineer works closely with cross-functional teams and contributes to continuous improvement of software quality practices.

Tasks and Responsibilities:

Provide software quality support across the Software Development Life Cycle (SDLC) for assigned program(s)

Collaborate with cross-functional teams (Software Development, Program Management, Product Security, etc.) to support execution of quality activities

Provide support on software development projects through review and approval of deliverables, including:

Software Development Plans, Verification Plans, Validation Plans

Product/Software Requirements

Software Architectural and Design Documents

Test Protocols, Requirement Traceability Matrix, Test Reports

Cybersecurity and risk-related documentation

Assist teams in determining verification and validation needs and requirements

Participate in software risk management activities throughout the product lifecycle

Participate in design reviews to support effective development, transfer, and maintenance of software products

Provide support for software-related quality issues (e.g., complaints, CAPA), including investigation and resolution activities

Identify opportunities for process improvements and support implementation of continuous improvements in the Software Quality Program

Support development and delivery of training on software quality processes and practices

Provide support for new technology areas (e.g., AI/ML, Cybersecurity, Cloud) as applicable to software systems and tools

Support internal and external audits related to product software and software quality processes

Escalate risks and issues as appropriate to ensure timely visibility and resolution

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:

2+ years’ experience in (software) quality engineering or related role in a regulated industry

Working knowledge of applicable industry standards and regulations (e.g., IEC 62304, ISO 13485, 21 CFR)

Basic understanding of software development lifecycle (SDLC) processes and software engineering best practices

Ability to execute assigned quality tasks with guidance and direction

Experience working with cross-functional teams in a collaborative environment

Good interpersonal, verbal, and written communication skills

Ability to apply core Quality Engineering principles, including documentation and risk management basics

Ability to work in a fast-paced and dynamic environment

Experience in a global delivery model preferred

Occasional travel may be required

Willingness to work in shifts to support the US region (No night shift required)

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.

Software Quality Engineer 2

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