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 role demands a seasoned expert with extensive experience in quality assurance processes, regulatory compliance, and team management

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while acting 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 maintaining liaison with individuals and units within or outside the organization to ensure adherence to Quality Management Systems and safety requirements.

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 role demands a seasoned expert with extensive experience in quality assurance processes, regulatory compliance, and team management.

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 supervise 4-5 direct reports

Nice-to-have

  • Master's degree or Doctorate preferred
  • Strong communication skills in English
  • Positive can-do attitude in high energy environment
  • Experience with global customer base interaction
  • Proficiency in Microsoft Office suite

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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