Sr. Quality Engineer

075

Not specified
Bachelor's degree in engineering
7+ years progressive engineering experience
Fda regulations and qms knowledge
Integer is seeking a Sr. Quality Engineer to ensure the production of high-quality products for medical device OEMs. The ideal candidate will have substantial engineering experience, strong problem-solving skills, and a commitment to upholding the company’s core values

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure product quality meets or exceeds customer expectations.
  • You will lead continuous improvement projects, manage complaint investigations, and drive plant CAPA activities using statistical quality control methods.
  • This position requires adherence to FDA regulations, ISO standards, and the company's core values while supporting regulatory inspections and audits.

Matching Summary

Match Score: 85

Integer is seeking a Sr. Quality Engineer to ensure the production of high-quality products for medical device OEMs. The ideal candidate will have substantial engineering experience, strong problem-solving skills, and a commitment to upholding the company’s core values.

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Strong knowledge of FDA and QSR regulations
  • Six Sigma Green Belt minimum required
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter