Quality Engineer I

Integer

Base: $64,350 - $85,800; bonus/equity: cash-based ...
Fda regulations compliance
Quality management systems (qms)
Device history records maintenance
The primary purpose of this position is to ensure that internal and external customer expectations are met or exceeded while adhering to FDA regulations and Quality Management Systems

Job Summary

  • The primary purpose of this position is to ensure that internal and external customer expectations are met or exceeded while adhering to FDA regulations and Quality Management Systems.
  • You will support regulatory inspections, monitor manufacturing compliance with Device Master Records, and lead complaint investigations including root cause analysis.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and immediate eligibility for paid time off.

Matching Summary

The primary purpose of this position is to ensure that internal and external customer expectations are met or exceeded while adhering to FDA regulations and Quality Management Systems.

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 optimization skills
  • 5S workplace organization
  • Data analysis practices

Key Requirements

  • Entry level engineer experience
  • Knowledge of QMS and FDA regulations
  • Ability to perform root cause analysis

Work Rights

Not specified

Tailored Resume

Cover Letter