Principal Quality Engineer

Integer

**
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 to provide strategic quality guidance and leadership within the organization, ensuring compliance with regulatory standards and driving continuous improvement. The role requires extensive engineering knowledge, strong communication skills, and the ability to collaborate across teams to enhance quality and performance. **

Job Summary

  • This role provides strategic quality guidance as a subject matter expert to support Integer's goals in the medical device and energy markets.
  • The incumbent will lead regulatory agency inspections, manage non-conforming material processes, and ensure compliance with FDA regulations and QMS requirements.
  • You will mentor up to 4-5 direct reports while collaborating globally to drive continuous improvement and innovation in manufacturing processes.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within the organization, ensuring compliance with regulatory standards and driving continuous improvement. The role requires extensive engineering knowledge, strong communication skills, and the ability to collaborate across teams to enhance quality and performance. **

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, FMEA, and root cause analysis
  • Ability to lead product transfers and validation

Nice-to-have

  • Master's degree or Doctorate preferred
  • Experience with global customer base interaction
  • Strong coaching and mentoring capabilities
  • Familiarity with 5 Sigma quality journey
  • Positive can-do attitude in high-energy environment

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • FDA and ISO regulatory knowledge
  • Leadership of audits and investigations

Work Rights

Not specified

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