Quality Engineer Ii- Alden

Integer

Alden, NY, United States
Min 70,500; max 103,400; benefits: medical, dental...
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, applying 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, applying 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.

Matching Summary

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

Salary

Min 70,500; Max 103,400; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with match, 80 hours holidays, PTO

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • Bill of Materials (BOMs) review
  • Process validations and capability studies
  • Non-conforming material disposition
  • Root cause analysis

Nice-to-have

  • Customer focus and success
  • Innovation and collaboration
  • Open and honest communication
  • Positive, can-do attitude
  • Calm demeanor in high-energy environment

Key Requirements

  • Bachelor's degree in engineering or related field
  • 3+ years relevant experience
  • 7+ years relevant experience (if no degree)
  • 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