Principal Quality Engineer

Integer

Not specified (assumed to be on-site or hybrid based on the nature of the role).
10+ years progressive engineering experience
Bachelor's degree in engineering field
Fda regulations and qms knowledge
Integer is seeking a Principal Quality Engineer to provide strategic quality guidance within the medical device manufacturing sector, emphasizing innovation, collaboration, and integrity. The ideal candidate will have over 10 years of engineering experience and a strong understanding of quality management systems relevant to the industry

Job Summary

  • The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive engineering knowledge.
  • You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • As a subject matter expert, you are expected to solve unique and complex problems with a broad impact on the business while mentoring up to five direct reports.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer to provide strategic quality guidance within the medical device manufacturing sector, emphasizing innovation, collaboration, and integrity. The ideal candidate will have over 10 years of engineering experience and a strong understanding of quality management systems relevant to the industry.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • Bachelor's degree in engineering field
  • FDA regulations and QMS knowledge
  • ISO and international standards awareness
  • Root cause analysis and CAPA leadership

Nice-to-have

  • Master's degree or Doctorate preferred
  • Experience with global customer base
  • Strong written and oral communication skills
  • Ability to mentor and supervise engineers
  • Positive can-do attitude in high energy environment

Key Requirements

  • 10+ years of progressive engineering experience
  • Bachelor's degree in engineering or related technical field
  • Knowledge of FDA regulations, ISO, QSR, UL, MDD, TGA
  • Experience leading continuous improvement projects
  • Proficiency in Microsoft Office

Work Rights

Not specified

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