Quality Engineer Ii- Alden

Integer

Base: 70,500 - 103,400; bonus/equity: cash-based i...
Not specified (assumed to be hybrid based on industry standards).
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Integer is seeking a Quality Engineer II to enhance the quality and compliance of their medical device manufacturing processes. The role involves utilizing advanced quality tools, collaborating with cross-functional teams, and ensuring adherence to regulatory standards while contributing to continuous improvement initiatives

Job Summary

  • Perform work involving general engineering methods and tools, utilizing advanced quality tools and concepts to resolve acute or chronic problems in the medical device industry.
  • Support regulatory and agency inspections, audits, and investigations, ensuring compliance with QMS, FDA regulations, and other requirements while monitoring manufacturing and maintaining Device History Records.
  • The total rewards program includes base salary, cash-based incentives, comprehensive benefits with immediate eligibility, parental leave, 401(k) with company matching, and paid time off.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer II to enhance the quality and compliance of their medical device manufacturing processes. The role involves utilizing advanced quality tools, collaborating with cross-functional teams, and ensuring adherence to regulatory standards while contributing to continuous improvement initiatives.

Salary

Base: 70,500 - 103,400; Bonus/Equity: cash-based incentive program; 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)
  • Bill of Materials (BOM) review
  • Test method validation protocols
  • Non-conforming material disposition

Nice-to-have

  • Collaborative team environment
  • Continuous improvement mindset
  • Calm demeanor in changing environment
  • Positive, can-do attitude

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

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