Principal Quality Engineer

Integer

Not specified (assumed to be hybrid or onsite based on company culture).
10+ years progressive engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within the organization. The role emphasizes innovation, collaboration, and adherence to quality management systems, requiring a seasoned expert with over ten years of experience in engineering and a strong understanding of regulatory standards

Job Summary

  • This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the field.
  • The successful candidate will lead regulatory and agency inspections while ensuring compliance with FDA regulations and Quality Management Systems.
  • You will be responsible for developing new approaches to complex problems and leading continuous improvement projects across the organization.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within the organization. The role emphasizes innovation, collaboration, and adherence to quality management systems, requiring a seasoned expert with over ten years of experience in engineering and a strong understanding of regulatory standards.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage non-conforming material processes
  • Develop test method validations

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Strong written and oral communication
  • Mentoring and coaching capabilities
  • Global customer interaction experience

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • 10+ years of progressive engineering experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

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