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
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 is designed to attract, retain, and motivate associates to contribute to Integer’s success, including 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
  • Device History Records (DHR)
  • test method validations
  • process validations
  • non-conforming material disposition

Nice-to-have

  • continuous improvement projects
  • collaboration with cross-functional teams
  • calm demeanor in high-energy environment
  • positive can-do attitude

Key Requirements

  • Bachelor's degree in engineering or related field with 3 years relevant experience
  • 7+ years relevant experience without degree
  • Awareness of Domestic and International Regulations (ISO, QSR, MDD)
  • Good knowledge in Microsoft Office
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter