Sr. Quality Engineer

489

Bachelor's degree in engineering
7+ years progressive engineering experience
Fda regulations and qms knowledge
This role involves applying intensive engineering knowledge to ensure product quality for medical device OEMs and specialized battery applications

Job Summary

  • This role involves applying intensive engineering knowledge to ensure product quality for medical device OEMs and specialized battery applications.
  • The successful candidate will lead continuous improvement projects, manage complaint investigations, and support regulatory inspections and audits.
  • You are expected to adhere to Integer's core values of Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity while driving towards 5 Sigma quality goals.

Matching Summary

This role involves applying intensive engineering knowledge to ensure product quality for medical device OEMs and specialized battery applications.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 7+ years progressive engineering experience
  • FDA regulations and QMS knowledge
  • Statistical quality control (Cpk, DOE)
  • Root cause analysis and CAPA leadership

Nice-to-have

  • Master's degree in engineering field
  • Six Sigma Black Belt certification
  • Experience leading product transfers
  • Mentoring junior engineers
  • ISO and international regulatory awareness

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of progressive engineering experience
  • Strong knowledge of FDA regulations and QMS
  • Six Sigma Green Belt minimum required
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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