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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
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- 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.
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