Sr. Quality Engineer

538

Bachelor's degree in engineering
7+ years progressive engineering experience
Fda regulations and qms knowledge
The primary purpose of this role is to apply intensive engineering knowledge to ensure product quality meets customer expectations in the medical device industry

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure product quality meets customer expectations in the medical device industry.
  • You will lead continuous improvement projects, manage plant CAPA activities, and support regulatory inspections while adhering to strict FDA and ISO regulations.
  • This position requires a subject matter expert with 7+ years of experience who can independently resolve complex technical problems and mentor other engineers.

Matching Summary

The primary purpose of this role is to apply intensive engineering knowledge to ensure product quality meets customer expectations in the medical device industry.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 7+ years progressive engineering experience
  • FDA regulations and QMS knowledge
  • Statistical quality control (Cpk, DOE)
  • CAPA and complaint investigation leadership

Nice-to-have

  • Master's degree preferred
  • Six Sigma Black Belt certification
  • ISO and international standards awareness
  • Mentoring and supervising engineers
  • Continuous improvement mindset

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of progressive engineering experience
  • Knowledge of FDA regulations and QMS
  • Six Sigma Green Belt minimum required
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter