Mfg/ops Quality Engineer 1

Illumina

Base: $62,900 - $94,300; bonus/equity: variable ca...
Not specified
Bachelor's degree in engineering or science
Knowledge of 21cfr 820 iso 13485 iso 14971
Experience with fda and iso compliance
Illumina is seeking a Mfg/Ops Quality Engineer 1 to support quality activities in a manufacturing environment. The ideal candidate will have a background in engineering or science, with experience in quality assurance within regulated settings, particularly in in-vitro diagnostics

Job Summary

  • This role supports day-to-day sustaining activities within a manufacturing environment while ensuring GMP compliance.
  • The position requires coordinating issue resolution using a risk-based approach and reviewing validation reports for gaps.
  • Illumina offers competitive compensation including variable cash programs, equity, and comprehensive benefits like health/dental/vision.

Matching Summary

Match Score: 75

Illumina is seeking a Mfg/Ops Quality Engineer 1 to support quality activities in a manufacturing environment. The ideal candidate will have a background in engineering or science, with experience in quality assurance within regulated settings, particularly in in-vitro diagnostics.

Salary

Base: $62,900 - $94,300; Bonus/Equity: Variable cash program and equity eligible; Benefits: Health/dental/vision, retirement, PTO

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering or Science
  • Knowledge of 21CFR 820 ISO 13485 ISO 14971
  • Experience with FDA and ISO compliance
  • Ability to manage non-conformances and CAPA
  • Strong communication and project management skills

Nice-to-have

  • Direct experience in IVD manufacturing
  • Proficiency with SAP ERP system
  • Adaptable to fast-paced dynamic environments
  • Cross-functional collaboration experience
  • Risk-based decision making capabilities

Key Requirements

  • 0-2 years experience in quality assurance
  • Regulated environment experience preferred
  • IVD manufacturing experience preferred
  • SAP knowledge preferred
  • No visa sponsorship available

Work Rights

Not specified

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