Principal Quality Engineer

Integer

Not specified (assume hybrid based on industry standards)
10+ years progressive engineering experience
Bachelor's degree in engineering or related field
Knowledge of fda regulations and iso standards
Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance to enhance medical device and niche battery manufacturing, ensuring adherence to quality management systems and regulatory standards. The ideal candidate will possess extensive engineering experience, strong leadership qualities, and a commitment to continuous improvement

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive quality knowledge principles.
  • You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • As a subject matter expert, you are expected to mentor engineers, supervise up to 5 direct reports, and drive continuous improvement projects across the organization.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance to enhance medical device and niche battery manufacturing, ensuring adherence to quality management systems and regulatory standards. The ideal candidate will possess extensive engineering experience, strong leadership qualities, and a commitment to continuous improvement.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • Bachelor's degree in engineering or related field
  • Knowledge of FDA regulations and ISO standards
  • Experience leading regulatory inspections and audits
  • Expertise in CAPA and root cause analysis

Nice-to-have

  • Master's degree or Doctorate preferred
  • Strong communication skills in English
  • Ability to work independently and collaboratively
  • Positive can-do attitude with high energy
  • Experience with global customer base interaction

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • FDA and ISO regulatory knowledge
  • Leadership of inspections and audits
  • CAPA and root cause analysis expertise

Work Rights

Not specified

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