Principal Quality Engineer

115

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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 for manufacturing and quality assurance in medical devices and niche battery applications. The ideal candidate should have over 10 years of relevant engineering experience and possess strong leadership and technical skills to ensure compliance with quality standards while driving continuous improvement. **

Job Summary

  • This role provides strategic quality guidance as a subject matter expert to support the company's goals in medical device manufacturing.
  • The incumbent will lead regulatory and agency inspections, manage non-conforming material processes, and ensure adherence to FDA regulations and QMS.
  • You will mentor up to five direct reports while collaborating with global customers to drive product transfers and continuous improvement initiatives.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to provide strategic quality guidance for manufacturing and quality assurance in medical devices and niche battery applications. The ideal candidate should have over 10 years of relevant engineering experience and possess strong leadership and technical skills to ensure compliance with quality standards while driving 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, FMEA, and root cause analysis
  • Ability to lead continuous improvement projects

Nice-to-have

  • Master's degree or Doctorate preferred
  • Experience with global customer base interactions
  • Strong coaching and mentoring capabilities
  • Positive can-do attitude in high-energy environment
  • Proficiency in Microsoft Office suite

Key Requirements

  • 10+ years of progressive engineering experience
  • Bachelor's degree in engineering or technical field
  • Master's degree or Doctorate (preferred)
  • Knowledge of Domestic and International Regulations (ISO, QSR, UL, MDD, TGA)

Work Rights

Not specified

Tailored Resume

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