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, 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
  • FDA regulations and QMS knowledge
  • Device History Records maintenance
  • Statistical quality control tools

Nice-to-have

  • Ability to work independently
  • Mentoring technicians and inspectors
  • Continuous improvement project participation
  • Effective written and verbal communication
  • Supplier quality management skills

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Experience in medical device or regulated manufacturing
  • Proficiency in Minitab and Microsoft Office

Work Rights

Not specified

Tailored Resume

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