Quality Engineer Ii- Alden

Integer

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 to join their team in enhancing the quality of medical devices and niche batteries. The role focuses on applying engineering concepts to ensure compliance with quality standards and regulations while fostering a culture of innovation, collaboration, and integrity. **

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 to join their team in enhancing the quality of medical devices and niche batteries. The role focuses on applying engineering concepts to ensure compliance with quality standards and regulations while fostering a culture of innovation, collaboration, and integrity. **

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 match, 80 hours holidays, paid time off

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • test method validations
  • process validations
  • non-conforming material disposition

Nice-to-have

  • continuous improvement projects
  • collaboration with cross-functional teams
  • calm demeanor in high-energy environment
  • positive can-do attitude

Key Requirements

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience
  • 7+ years relevant experience (if education requirement not met)
  • Awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
  • Competencies in written and oral English communications

Work Rights

Not specified

Tailored Resume

Cover Letter