Quality Engineer Ii

Integer

Pembroke Pines, FL, 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 engineering 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 engineering 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, and monitor manufacturing of assigned products, assuring compliance with DMR.
  • Our total rewards program includes base salary, a cash-based incentive program, and a comprehensive benefits package including medical, dental, vision, disability, life insurance, and 401(k) with company matching.

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 engineering in the medical device industry.

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • Test method validation
  • Non-conforming material process
  • Root cause analysis

Nice-to-have

  • Collaborate with cross-functional teams
  • Positive, can-do attitude
  • Calm demeanor in high-energy environment
  • Manufacturing Excellence strategies

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter