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 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, 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 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 validation protocols
  • Non-conforming material disposition
  • CAPA activities

Nice-to-have

  • Collaborate with cross-functional teams
  • Positive, can-do attitude
  • Calm demeanor in high-energy environment
  • Continuous improvement suggestions

Key Requirements

  • Bachelor's degree in engineering or related field and 3 years relevant experience
  • 7+ years relevant experience without degree
  • Awareness of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
  • Good knowledge in Microsoft Office

Work Rights

Not specified

Tailored Resume

Cover Letter