Design Quality Engineer 2

Illumina
San Diego, CA
Category Engineering
Job Description
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.

Requirements

  • Provide Quality oversight to ensure Illumina’s products and processes are safe, effective, and meet customer performance needs throughout the product lifecycles
  • Provide support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors
  • Ensure products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems
  • Lead product risk management activities
  • Audit the quality and completeness of product Design History Files and/or Device Master Record
  • Facilitate participation in the technical discussions and risk-based decision making utilizing knowledge of applicable technology
  • Support issue resolution using a risk-based approach
  • Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
  • Utilize quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
  • Define and/or create processes to align with quality standards and business practices

Benefits

  • Access to genomics sequencing
  • Family planning
  • Health/dental/vision
  • Retirement benefits
  • Paid time off
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