Quality Engineer Ii

Integer

Base: $77,570 - $113,740; bonus/equity: cash-based...
Bachelor's degree in engineering
2-5 years quality engineering experience
Knowledge of fda regulations and iso standards
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 plant 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, disability, life insurance, and a 401(k) plan with company matching contributions.

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 available; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) match

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering
  • 2-5 years quality engineering experience
  • Knowledge of FDA regulations and ISO standards
  • Experience with CAPA and root cause analysis
  • Proficiency in Minitab and statistical tools

Nice-to-have

  • Ability to work independently and in teams
  • Strong written and verbal communication skills
  • Mentoring experience for technicians and inspectors
  • Participation in continuous improvement projects
  • Experience with product transfers

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Preferably in medical device or regulated manufacturing

Work Rights

Not specified

Tailored Resume

Cover Letter