Design Quality Engineer 2 - San Diego

Illumina Hub International Ltd

San Diego, US
Base: $74,900 - $112,300; bonus/equity: variable c...
Design control activities
Product and process conformance
Quality system regulations and standards
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world

Job Summary

  • At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world.
  • In this cross-functional quality role, you will actively participate in design control activities, ensuring product and process conformance to applicable safety and quality system regulations and standards.
  • 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.

Matching Summary

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world.

Salary

Base: $74,900 - $112,300; Bonus/Equity: variable cash programs (bonus or commission) and may receive equity; Benefits: wide range of benefits including genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off

Skills & Requirements

Must-have

  • Design control activities
  • Product and process conformance
  • Quality system regulations and standards
  • Cross-functional project teams
  • Risk management activities
  • Design History Files
  • Device Master Record

Nice-to-have

  • Team oriented with excellent communication
  • Excellent cross-functional collaboration
  • Detailed oriented and well organized
  • Adaptable to fast-paced environment

Key Requirements

  • Bachelor's Degree Engineering and/or Science Degree
  • 2-5 years of related experience
  • 2-5 years experience FDA/ISO regulated industry
  • Quality Certification (e.g. CQE) Upon Hire
  • Technical expertise in Assay Development, Bioinformatics, MFG Quality Engineering, Clinical Trials, Instrument Development
  • Knowledge of FDA regulatory environment (CFR 820), 501k, ISO 14971, ISO 13485 and IVDR

Work Rights

Not specified

Tailored Resume

Cover Letter