Quality Engineer Ii- Alden

Integer

Base: 70,500 - 103,400; bonus/equity: cash-based i...
Not specified (assumed onsite based on job nature)
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Integer is seeking a Quality Engineer II to join their team, focusing on ensuring quality in medical device manufacturing through engineering methods and regulatory compliance. The role requires collaboration with cross-functional teams to enhance product integrity and support continuous improvement initiatives

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, monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including base salary, cash-based incentive program, comprehensive benefits package, 401(k) plan with company matching, and paid time off.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer II to join their team, focusing on ensuring quality in medical device manufacturing through engineering methods and regulatory compliance. The role requires collaboration with cross-functional teams to enhance product integrity and support 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 match, 80 hours holiday, PTO

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • test method validations
  • process validations and capability studies
  • Non-conforming Material Process

Nice-to-have

  • Manufacturing Excellence
  • Market Focused Innovation
  • behavior-based safety programs
  • positive, can-do attitude
  • calm demeanor

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 Domestic and International Regulations and Industry Standards
  • Good knowledge in Microsoft Office

Work Rights

Not specified

Tailored Resume

Cover Letter