Principal Quality Engineer

Integer

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 in the medical device manufacturing sector. The ideal candidate will have over 10 years of engineering experience, a strong technical background, and the ability to work independently and collaboratively

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals as a subject matter expert.
  • You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • This role requires applying intensive knowledge of engineering principles to resolve acute or chronic problems while ensuring compliance with FDA regulations and QMS.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance and leadership in the medical device manufacturing sector. The ideal candidate will have over 10 years of engineering experience, a strong technical background, and the ability to work independently and collaboratively.

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
  • Ability to supervise 4-5 direct reports

Nice-to-have

  • Master's degree or Doctorate preferred
  • Strong written and oral communication skills
  • Positive can-do attitude with calm demeanor
  • Experience with global customer base interaction
  • Proven track record in continuous improvement

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • FDA and ISO regulatory knowledge
  • Supervisory experience for 4-5 engineers

Work Rights

Not specified

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