Sr. Quality Engineer

576

Bachelor's degree in engineering
7+ years progressive engineering experience
Fda regulations and qms compliance
The role involves ensuring customer expectations are met while developing unique approaches to complex engineering problems in the medical device industry

Job Summary

  • The role involves ensuring customer expectations are met while developing unique approaches to complex engineering problems in the medical device industry.
  • Candidates will lead continuous improvement projects, manage complaint investigations, and ensure adherence to FDA regulations and Quality Management Systems.
  • This position requires a subject matter expert with 7+ years of experience who can independently resolve acute or chronic technical issues.

Matching Summary

The role involves ensuring customer expectations are met while developing unique approaches to complex engineering problems in the medical device industry.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 7+ years progressive engineering experience
  • FDA regulations and QMS compliance
  • CAPA and root cause analysis
  • Statistical quality control (Cpk, DOE)
  • Process validation and capability studies

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • ISO and international regulatory knowledge
  • Mentoring and supervising engineers
  • Continuous improvement leadership
  • 5 Sigma journey participation

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of progressive engineering experience
  • Six Sigma Green Belt (Black Belt preferred)
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter