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 monitoring manufacturing processes, reviewing Bill of Materials changes, and leading test method validations while ensuring compliance with FDA regulations.
  • 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 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: Comprehensive package with immediate eligibility including medical, dental, vision, 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
  • Process validation and capability studies

Nice-to-have

  • Ability to work independently and in team environment
  • Effective written and verbal communication skills
  • Experience with supplier quality resolution
  • Continuous improvement project participation
  • Mentoring technicians and inspectors

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter