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 with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

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) matching

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

  • Experience in medical device industry
  • Ability to work independently
  • Strong written and verbal communication
  • Mentoring technicians and inspectors
  • Continuous improvement project participation

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Proficiency in Minitab and Microsoft Office
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

Cover Letter