Staff Software Quality Engineer

Illumina   •  

San Diego, CA

Industry: Biotech/Pharma


5 - 7 years

Posted 397 days ago


  • 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
  • Provide Quality Oversight for the Manufacturing Execution System
  • 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 company’s policies and practices.
  • Other such duties as may be determined by Management


  • 5 to 7 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
  • Experience with multi-site implementations of a Manufacturing Execution System
  • 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


  • Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical or related field required