Software Quality Engineer 2
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Job Summary
PositionSummary:
SoftwareQuality Engineer2provides support to Illuminas software development teams to ensureproductsoftware isdeveloped in compliance withIlluminas policies/procedures and applicableregulatory requirements (e.g.21CFR820QMSR)andInternational 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.
TasksandResponsibilities:
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 supportonsoftware development projectsthroughreviewandapproval 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
Cybersecurityand risk-related documentation
Assistteams indeterminingverification 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
Identifyopportunities 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 fornew technologyareas (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 asappropriate toensuretimelyvisibility and resolution
Support other areas of the Quality System and performadditionaltasks as defined by management
All listed tasks and responsibilities aredeemedessential functions to this position; however business conditions may require reasonableaccommodationforadditionaltasksand responsibilities.
PreferredEducation:
Bachelors degree inComputerScience Software EngineeringBioinformatics Biomedical or related discipline
JobRequirements:
2years experience in (software) quality engineering or related role in aregulated industry
Workingknowledge of applicableindustry standardsand regulations(e.g.IEC 62304ISO 13485 21 CFR)
Basic understandingofsoftware 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
Willingness to work in shifts to support the US region (No night shift)
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 To learn more visit: 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.
Required Experience:
IC
