Software Quality Engineer 2

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.

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 companys policies and practices
• Other such duties as may be determined by Management

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 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

Listed responsibilities are an essential but not exhaustive list of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Experience/Education:

• Typically requires a Bachelors degree and a minimum of 3 years of related experience; or equivalent work experience.

The estimated base salary range for the Software Quality Engineer 2 role based in the United States of America is: $73400 - $110200. Should the level or location of the role change during the hiring process the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including but not limited to an individuals qualifications location where the role is to be performed internal equity and alignment with market data. Additionally all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work including access to genomics sequencing family planning health/dental/vision retirement benefits and paid time off.

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.