Quality Engineer I

Integer

Base: $64,350 - $85,800; bonus/equity: cash-based ...
Fda regulations compliance
Quality management systems (qms)
Device history records maintenance
This role supports regulatory inspections, audits, and investigations to ensure product design and manufacturing quality meet FDA regulations

Job Summary

  • This role supports regulatory inspections, audits, and investigations to ensure product design and manufacturing quality meet FDA regulations.
  • The engineer will develop inspection procedures, validate test methods, and lead non-conforming material disposition processes to maintain product integrity.
  • Integer offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and paid time off immediately upon eligibility.

Matching Summary

This role supports regulatory inspections, audits, and investigations to ensure product design and manufacturing quality meet FDA regulations.

Salary

Base: $64,350 - $85,800; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, 401(k) match

Skills & Requirements

Must-have

  • FDA regulations compliance
  • Quality Management Systems (QMS)
  • Device History Records maintenance
  • Root cause analysis
  • CAPA activities
  • Test method validation

Nice-to-have

  • Continuous improvement projects
  • Collaborative team environment
  • Process capability studies
  • 5S workplace organization
  • Standardized problem solving

Key Requirements

  • Entry level engineering position
  • Knowledge of QMS and FDA regulations
  • Experience with FMEA and Control Plans

Work Rights

Not specified

Tailored Resume

Cover Letter