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 Integer's 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 Integer's 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 participate in continuous improvement projects to enhance product and process quality.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, 401(k) matching, and 80 hours of designated holidays per year.

Matching Summary

The primary purpose of this position is to ensure that Integer's 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 available; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) match

Skills & Requirements

Must-have

  • FDA regulations compliance
  • Quality Management Systems QMS
  • Device History Records maintenance
  • Root cause analysis CAPA
  • Test method validation protocols
  • Bill of Materials review

Nice-to-have

  • Continuous improvement projects
  • Collaborative team environment
  • Process capability studies
  • 5S workplace organization
  • Data analysis practices

Key Requirements

  • Entry level engineer experience
  • Knowledge of FDA regulations
  • Understanding of QMS requirements

Work Rights

Not specified

Tailored Resume

Cover Letter