Quality Engineer I

Integer

Base: $64,350 - $85,800; bonus/equity: cash-based ...
Fda regulations compliance
Device history records maintenance
Bill of materials review
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 DMRs, and lead complaint investigations including CAPA activities and root cause analysis.
  • The company offers a comprehensive benefits package including 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 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
  • Device History Records maintenance
  • Bill of Materials review
  • FMEA and Control Plans
  • Test method validation protocols
  • CAPA and root cause analysis
  • Incoming In-Process Final Inspection

Nice-to-have

  • Continuous improvement projects
  • 5S workplace organization
  • Collaborative team environment
  • Data analysis practices
  • Product transfer support
  • Standardized problem solving methodologies

Key Requirements

  • Entry level engineer experience
  • Knowledge of QMS and FDA regulations
  • Ability to work under guidance of senior engineers

Work Rights

Not specified

Tailored Resume

Cover Letter