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 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.
  • Employees are immediately eligible to participate in the 401(k) plan with company matching contributions and receive a comprehensive benefits package including medical, dental, and vision.
  • The role involves leading complaint investigations, participating in plant CAPA activities, and reviewing the adequacy of changes to Bill of Materials and Assembly Procedures.

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; Benefits: Medical, dental, vision, disability, life insurance, 401(k) with 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 (Cpk, DOE)
  • CAPA and root cause analysis

Nice-to-have

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

Key Requirements

  • Minimum Bachelor's Degree in Engineering
  • 2-5 years quality engineering experience
  • Preferably in medical device or regulated manufacturing

Work Rights

Not specified

Tailored Resume

Cover Letter