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 that the Quality System requirements are adhered to for medical device manufacturing

Job Summary

  • The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing.
  • The role involves supporting regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Employees receive a comprehensive benefits package including immediate eligibility for 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 that the Quality System requirements are adhered to 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 QMS knowledge
  • Device History Records maintenance
  • Statistical quality control (Cpk, DOE)
  • Minitab proficiency

Nice-to-have

  • Ability to work independently and in teams
  • Strong written and verbal communication skills
  • Experience with supplier quality resolution
  • Continuous improvement project participation
  • Root cause analysis expertise

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