Quality Engineer Ii- Alden

Integer

Alden, United States
Base: 70,500 - 103,400; bonus/equity: cash-based i...
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Quality management systems (qms)
Fda regulations
Device history records (dhr)
** Integer is seeking a Quality Engineer II in Alden, USA, to contribute to quality assurance in the medical device industry. The role involves applying engineering concepts to resolve quality issues, support manufacturing processes, and ensure compliance with regulatory standards. **

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 engineering 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 base salary, a cash-based incentive program, and a comprehensive benefits package.

Matching Summary

Match Score: 75

** Integer is seeking a Quality Engineer II in Alden, USA, to contribute to quality assurance in the medical device industry. The role involves applying engineering concepts to resolve quality issues, support manufacturing processes, and ensure compliance with regulatory standards. **

Salary

Base: 70,500 - 103,400; Bonus/Equity: Cash-based incentive program; Benefits: Comprehensive benefits package with immediate eligibility

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • Test method validation protocols
  • Non-conforming material disposition
  • 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
  • 3+ years relevant experience
  • 7+ years relevant experience (alternative)
  • Awareness of Domestic and International Regulations
  • Good knowledge in Microsoft Office

Work Rights

Not specified

Tailored Resume

Cover Letter