Quality Engineer Ii

Integer

Trenton, GA, United States
Quality management systems (qms)
Fda regulations
Device history records (dhr)
The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry

Job Summary

  • The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry.
  • You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Our total rewards program includes base salary, a cash-based incentive program, and a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

Matching Summary

The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry.

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • test method validations
  • process validations
  • non-conforming material process

Nice-to-have

  • calm demeanor
  • positive can-do attitude
  • Manufacturing Excellence
  • Market Focused Innovation

Key Requirements

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience
  • 7+ years relevant experience (if education requirement not met)
  • Awareness of Domestic and International Regulations and Industry Standards

Work Rights

Not specified

Tailored Resume

Cover Letter