Principal Quality Engineer

599

Not specified
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 a culture focused on customer success, innovation, and collaboration. The ideal candidate should possess extensive engineering experience, particularly in quality management systems, and demonstrate strong problem-solving skills. The role offers opportunities for professional development and engagement in innovative projects that enhance patient lives. ###

Job Summary

  • This role serves as a strategic authority providing quality guidance to support the company's goals in the medical device and energy markets.
  • The incumbent will lead regulatory agency inspections, manage non-conforming material processes, and ensure adherence to FDA regulations and Quality Management Systems.
  • Candidates must possess over 10 years of engineering experience and demonstrate the ability to solve complex problems while mentoring up to five direct reports.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership within a culture focused on customer success, innovation, and collaboration. The ideal candidate should possess extensive engineering experience, particularly in quality management systems, and demonstrate strong problem-solving skills. The role offers opportunities for professional development and engagement in innovative projects that enhance patient lives. ###

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 continuous improvement

Nice-to-have

  • Master's degree or Doctorate preferred
  • Experience with 5 Sigma methodology
  • Strong cross-functional collaboration skills
  • Global customer interaction experience
  • Mentorship and team supervision capabilities

Key Requirements

  • 10+ years of progressive engineering experience
  • Bachelor's degree in engineering or technical field
  • Familiarity with QSR, ISO, UL, MDD, TGA regulations
  • Supervisory experience managing 4-5 engineers

Work Rights

Not specified

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