Quality Engineer Ii

Integer

Base: $77,570 - $113,740; bonus/equity: cash-based...
Bachelor's degree in engineering
2-5 years quality engineering experience
Fda regulations and qms knowledge
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing

Job Summary

  • The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing.
  • The role involves leading complaint investigations, participating in CAPA activities, and ensuring the disposition of non-conforming materials meets all regulatory requirements.
  • Employees are eligible for a comprehensive benefits package including medical, dental, vision, 401(k) matching, and 80 hours of company designated holidays per year.

Matching Summary

The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing.

Salary

Base: $77,570 - $113,740; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, 401(k) match

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering
  • 2-5 years quality engineering experience
  • FDA regulations and QMS knowledge
  • Device History Records maintenance
  • Statistical quality control tools

Nice-to-have

  • Experience in medical device industry
  • Ability to work independently
  • Strong written and verbal communication
  • Mentoring technicians and inspectors
  • Continuous improvement project participation

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Proficiency with Minitab and Microsoft Office

Work Rights

Not specified

Tailored Resume

Cover Letter