Quality Engineer Ii- Alden

Integer

Alden, Unknown, Unknown
Min 70,500 max 103,400; bonus/equity: cash-based i...
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Quality management systems (qms)
Fda regulations adherence
Device history records (dhr)
** Integer is seeking a Quality Engineer II for its Alden location to enhance its quality assurance processes in the medical device industry. The role involves applying engineering principles to resolve issues, ensure compliance with regulatory standards, and promote continuous improvement while adhering to the company’s core values. **

Job Summary

  • 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.
  • Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • The total rewards program includes base salary, cash-based incentive program, comprehensive benefits package with immediate eligibility, 401(k) plan with company matching, and paid time off.

Matching Summary

Match Score: 75

** Integer is seeking a Quality Engineer II for its Alden location to enhance its quality assurance processes in the medical device industry. The role involves applying engineering principles to resolve issues, ensure compliance with regulatory standards, and promote continuous improvement while adhering to the company’s core values. **

Salary

Min 70,500 Max 103,400; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with match

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

  • Collaborate with cross-functional teams
  • Maintain calm demeanor
  • Positive, can-do attitude
  • Continuous improvement suggestions

Key Requirements

  • Bachelor's degree in engineering or related field and 3 years relevant experience
  • 7+ years relevant experience without degree
  • Awareness of Domestic and International Regulations and Industry Standards
  • Proficiency in Microsoft Office

Work Rights

Not specified

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