Npi Quality Engineer Iii

Integer

**
Npi project support
Develop new test methods
Process validation and capability studies
** Integer is seeking a NPI Quality Engineer III to lead quality assurance efforts in New Product Introduction projects. The ideal candidate should possess strong engineering principles, problem-solving skills, and experience with regulatory compliance, particularly within the medical device industry. **

Job Summary

  • The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices to New Product Introduction (NPI) projects.
  • You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • You will lead continuous improvement projects and assist with product transfers, performing work on technical projects where you will follow Integer’s standard quality management and production system methodologies.

Matching Summary

Match Score: 75

** Integer is seeking a NPI Quality Engineer III to lead quality assurance efforts in New Product Introduction projects. The ideal candidate should possess strong engineering principles, problem-solving skills, and experience with regulatory compliance, particularly within the medical device industry. **

Skills & Requirements

Must-have

  • NPI project support
  • Develop new test methods
  • Process validation and capability studies
  • Root cause analysis
  • Risk management activities per ISO14971
  • Continuous improvement projects

Nice-to-have

  • Embed Quality mindset
  • Positive, can-do attitude
  • Calm demeanor in high-energy environment
  • Collaborate with others
  • Technical guidance to management

Key Requirements

  • Bachelor's degree in engineering or related field
  • 5+ years of progressive engineering experience
  • 10+ years of relevant experience (if education requirement not met)
  • 6 Sigma Green Belt (minimum), Black Belt preferred
  • Awareness of Domestic and International Regulations and Industry Standards

Work Rights

Not specified

Tailored Resume

Cover Letter