Principal Quality Engineer

Integer

Not specified (considering potential for hybrid or onsite work based on the nature of the role)
10+ years progressive engineering experience
Fda regulations and qms knowledge
Lead regulatory inspections and audits
Integer is seeking a Principal Quality Engineer responsible for providing strategic quality guidance and ensuring compliance with quality management systems in the medical device and niche battery manufacturing sectors. The ideal candidate should possess extensive engineering experience and demonstrate strong leadership, problem-solving, and communication skills

Job Summary

  • This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the field.
  • The successful candidate will lead regulatory and agency inspections while ensuring compliance with FDA regulations and Quality Management Systems.
  • You are expected to mentor up to 4-5 direct reports and collaborate with a global customer base to drive business opportunities.

Matching Summary

Match Score: 85

Integer is seeking a Principal Quality Engineer responsible for providing strategic quality guidance and ensuring compliance with quality management systems in the medical device and niche battery manufacturing sectors. The ideal candidate should possess extensive engineering experience and demonstrate strong leadership, problem-solving, and communication skills.

Skills & Requirements

Must-have

  • 10+ years progressive engineering experience
  • FDA regulations and QMS knowledge
  • Lead regulatory inspections and audits
  • Manage non-conforming material processes
  • Develop test method validation protocols

Nice-to-have

  • Master's degree or Doctorate preferred
  • ISO and international standards awareness
  • Mentoring and coaching engineering teams
  • Global customer interaction skills
  • Continuous improvement mindset

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • 10+ years of progressive engineering experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

Cover Letter