Sr. Quality Engineer

Integer

**
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Knowledge of fda regulations and iso standards
** Integer is seeking a Sr. Quality Engineer who will apply extensive engineering knowledge to ensure product quality and compliance with regulations in the medical device sector. The role emphasizes collaboration, innovation, and continuous improvement, aligning with Integer's core values. **

Job Summary

  • The role involves applying intensive engineering knowledge to ensure product quality and meet customer expectations in the medical device and battery manufacturing sectors.
  • Candidates will lead continuous improvement projects, manage complaint investigations, and ensure compliance with FDA regulations and Quality Management Systems.
  • This position requires a subject matter expert with 7+ years of experience who can mentor other engineers and drive initiatives toward 5 Sigma quality goals.

Matching Summary

Match Score: 75

** Integer is seeking a Sr. Quality Engineer who will apply extensive engineering knowledge to ensure product quality and compliance with regulations in the medical device sector. The role emphasizes collaboration, innovation, and continuous improvement, aligning with Integer's core values. **

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or related field
  • 7+ years of progressive engineering experience
  • Knowledge of FDA regulations and ISO standards
  • Experience with Six Sigma methodologies (Green Belt minimum)
  • Ability to lead continuous improvement projects
  • Proficiency in statistical quality control (Cpk, DOE)

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • Experience supervising engineering direct reports
  • Knowledge of international regulations (MDD, TGA)
  • Strong written and oral communication skills

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Six Sigma Green Belt certification required
  • Familiarity with QSR, ISO, and FDA regulations
  • US work authorization for applicants

Work Rights

Not specified

Tailored Resume

Cover Letter