Principal Quality Engineer

Integer

**
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 who will provide strategic quality guidance and leadership in ensuring compliance with quality standards within the medical device manufacturing sector. The ideal candidate should have over 10 years of experience in engineering roles, a solid understanding of regulatory standards, and a proactive approach to problem-solving in a fast-paced environment. **

Job Summary

  • This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry.
  • The successful candidate will lead regulatory inspections, manage non-conforming material processes, and drive continuous improvement projects across manufacturing operations.
  • You will serve as a coach and mentor for up to five direct reports while ensuring adherence to strict FDA regulations and company values.

Matching Summary

Match Score: 75

** Integer is seeking a Principal Quality Engineer who will provide strategic quality guidance and leadership in ensuring compliance with quality standards within the medical device manufacturing sector. The ideal candidate should have over 10 years of experience in engineering roles, a solid understanding of regulatory standards, and a proactive approach to problem-solving in a fast-paced environment. **

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 engineering teams
  • Proficiency in Quality Management Systems (QMS)

Nice-to-have

  • Master's degree or Doctorate preferred
  • Strong communication skills for global customers
  • Experience with product transfers and validation
  • Positive can-do attitude in high-energy environment
  • Knowledge of international regulations like MDD and TGA

Key Requirements

  • 10+ years of engineering experience
  • Bachelor's degree in engineering
  • FDA and ISO regulatory knowledge
  • Supervisory experience for 4-5 engineers
  • US work authorization implied by EEO statement

Work Rights

Not specified

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