Staff Qa Engineer

Dexcom Inc

Base: $111,100.00 - $185,100.00; bonus/equity: not...
Fda 21 cfr 820 compliance expertise
Iso 13485 quality management system
Design control and transfer strategy
The role involves serving as a technical leader on high-volume manufacturing automation equipment development teams within Dexcom's quality engineering division

Job Summary

  • The role involves serving as a technical leader on high-volume manufacturing automation equipment development teams within Dexcom's quality engineering division.
  • Candidates will drive Design Control strategies and ensure scalable manufacturing readiness while interpreting complex regulatory requirements like FDA 21 CFR 820.
  • The position offers the opportunity to work on life-changing CGM technology with comprehensive benefits and growth opportunities on a global scale.

Matching Summary

The role involves serving as a technical leader on high-volume manufacturing automation equipment development teams within Dexcom's quality engineering division.

Salary

Base: $111,100.00 - $185,100.00; Bonus/Equity: Not specified; Benefits: Comprehensive program including tuition reimbursement

Skills & Requirements

Must-have

  • FDA 21 CFR 820 compliance expertise
  • ISO 13485 Quality Management System
  • Design Control and transfer strategy
  • Process validation and FMEA methodology
  • Root cause analysis and Six Sigma
  • Statistical analysis with JMP and Excel

Nice-to-have

  • Cross-functional team leadership skills
  • Experience with global site alignment
  • Mentoring and training capabilities
  • Lean manufacturing knowledge
  • Strong communication across stakeholders

Key Requirements

  • Bachelor's degree in technical discipline
  • 8-12 years of related experience
  • Master's degree with 5-7 years experience
  • PhD with 2-4 years experience
  • Hands-on experience with ISO 13485

Work Rights

Not specified

Tailored Resume

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