Sr. Quality Engineer

Integer

**
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 medical devices and niche batteries. The role involves applying engineering principles, leading continuous improvement projects, and supporting compliance with regulatory standards. **

Job Summary

  • This role involves applying intensive engineering knowledge to ensure product quality and compliance with FDA regulations for medical device manufacturing.
  • The successful candidate will lead continuous improvement projects, manage non-conforming material processes, and support regulatory inspections and audits.
  • Candidates are expected to demonstrate strong problem-solving skills using statistical methods like Cpk and DOE while mentoring junior engineers.

Matching Summary

Match Score: 75

** Integer is seeking a Sr. Quality Engineer to ensure the production of high-quality medical devices and niche batteries. The role involves applying engineering principles, leading continuous improvement projects, and supporting compliance with regulatory standards. **

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 culture mindset

Key Requirements

  • Minimum Bachelor's degree in engineering or related field
  • 7+ years of progressive engineering experience
  • Strong technical foundation in problem-solving methodologies
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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