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 the generation and completion of protocols for test method validations while interfacing with Manufacturing Engineers on process validations.
  • Employees receive a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching.

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 included; 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
  • Statistical quality control tools (Cpk, DOE)
  • CAPA and root cause analysis expertise

Nice-to-have

  • Ability to work independently and in teams
  • Effective written and verbal communication skills
  • Experience mentoring technicians and inspectors
  • Proficiency in Minitab software
  • Continuous improvement project participation

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