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 iso standards 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 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 immediate 401(k) 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
  • FDA regulations and ISO standards knowledge
  • Device History Records maintenance
  • CAPA and root cause analysis expertise

Nice-to-have

  • Experience with statistical quality control tools
  • Ability to work independently and in teams
  • Strong written and verbal communication skills
  • Mentoring technicians and inspectors
  • Continuous improvement project participation

Key Requirements

  • Minimum Bachelor's Degree in Engineering or related field
  • 2-5 years quality engineering experience preferred in medical device
  • Proficiency in Minitab and Microsoft Office
  • Knowledge of QSR, ISO, UL, MDD, TGA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter