Principal Quality Engineer

809

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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 lead quality initiatives and ensure compliance with internal and external standards in the medical device manufacturing industry. The role requires extensive experience in engineering, project leadership, and a commitment to upholding the company's core values. **

Job Summary

  • This role serves as a subject matter expert providing strategic quality guidance to support the company's goals in medical device manufacturing.
  • The successful candidate will lead regulatory inspections, manage non-conforming material processes, and drive continuous improvement projects across the organization.
  • You will be responsible for mentoring engineers, supervising direct reports, and ensuring adherence to strict FDA regulations and quality management systems.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer to lead quality initiatives and ensure compliance with internal and external standards in the medical device manufacturing industry. The role requires extensive experience in engineering, project leadership, and a commitment to upholding the company's core values. **

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
  • Proficiency in Quality Management Systems (QMS)
  • Ability to supervise 4-5 direct reports

Nice-to-have

  • Master's degree or Doctorate preferred
  • Experience with global customer base interaction
  • Strong coaching and mentorship capabilities
  • Positive can-do attitude in high-energy environments
  • Fluency in English for international communication

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • FDA and ISO regulatory knowledge
  • Leadership of inspection teams
  • Supervision of 4-5 engineers

Work Rights

Not specified

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