Quality Engineer Ii- Alden

Integer

Base: 70,500 - 103,400; bonus/equity: cash-based i...
Not specified in the job description
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Integer is seeking a Quality Engineer II to enhance product quality and compliance in the medical device industry, emphasizing collaboration, innovation, and customer focus. The role involves utilizing advanced quality tools, supporting manufacturing processes, and ensuring adherence to 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, monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
  • 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 with immediate eligibility.

Matching Summary

Match Score: 85

Integer is seeking a Quality Engineer II to enhance product quality and compliance in the medical device industry, emphasizing collaboration, innovation, and customer focus. The role involves utilizing advanced quality tools, supporting manufacturing processes, and ensuring adherence to regulatory standards.

Salary

Base: 70,500 - 103,400; Bonus/Equity: cash-based incentive program; Benefits: comprehensive benefits package

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • Bill of Materials (BOM) review
  • test method validation protocols
  • process validation and capability studies

Nice-to-have

  • collaborate with cross-functional teams
  • calm demeanor in high-energy environment
  • positive, can-do attitude
  • Manufacturing Excellence strategies
  • Market Focused Innovation strategies

Key Requirements

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience
  • 7+ years relevant experience (if no degree)
  • Awareness of Domestic and International Regulations and Industry Standards
  • Good knowledge in Microsoft Office

Work Rights

Not specified

Tailored Resume

Cover Letter