Quality Engineer Ii- Alden

H1BConnect

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, 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.

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

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

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • Test method validations
  • 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
  • Continuous improvement suggestions

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 and Industry Standards
  • Good knowledge in Microsoft Office

Work Rights

Not specified

Tailored Resume

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