Quality Engineer Ii- Alden

Integer

Alden, NY, United States
Base: 70,500 - 103,400; bonus/equity: cash-based i...
Quality management systems (qms)
Fda regulations adherence
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 is designed to attract, retain, and motivate associates to contribute to Integer’s success, including base salary, a cash-based incentive program, and a comprehensive benefits package with immediate eligibility.

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.

Salary

Base: 70,500 - 103,400; Bonus/Equity: cash-based incentive program; Benefits: comprehensive benefits package

Skills & Requirements

Must-have

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

Nice-to-have

  • Collaborative team environment
  • Positive can-do attitude
  • Calm demeanor in production
  • Continuous improvement suggestions

Key Requirements

  • Bachelor's degree in engineering or related field
  • 3+ years relevant experience
  • Awareness of Domestic and International Regulations
  • Good knowledge in Microsoft Office
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter