Sr. Quality Engineer

Integer

Bachelor's degree in engineering
7+ years progressive engineering experience
Fda regulations and qms knowledge
The role involves applying intensive engineering knowledge to ensure product quality and meet customer expectations in the medical device industry

Job Summary

  • The role involves applying intensive engineering knowledge to ensure product quality and meet customer expectations in the medical device industry.
  • Candidates will lead continuous improvement projects, manage non-conforming material processes, and support regulatory inspections and audits.
  • The position requires a strong technical foundation with expertise in statistical analysis, root cause analysis, and adherence to FDA regulations.

Matching Summary

The role involves applying intensive engineering knowledge to ensure product quality and meet 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 in engineering
  • Six Sigma Black Belt certification
  • Mentoring and coaching engineers
  • ISO and international standards awareness
  • 5 Sigma journey participation

Key Requirements

  • Minimum Bachelor's degree in engineering or related field
  • 7+ years of progressive engineering experience
  • Strong knowledge of FDA regulations and Quality Management Systems
  • Experience with Six Sigma methodologies (Green Belt minimum)

Work Rights

Not specified

Tailored Resume

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