This role provides strategic quality guidance to support Integer's goals as a global organization serving Medical Device OEMs
Job Summary
This role provides strategic quality guidance to support Integer's goals as a global organization serving Medical Device OEMs.
The successful candidate will lead regulatory inspections, manage non-conforming materials, and ensure compliance with FDA regulations and Quality Management Systems.
As a subject matter expert, you will mentor up to five direct reports and drive continuous improvement projects across the manufacturing site.
Matching Summary
This role provides strategic quality guidance to support Integer's goals as a global organization serving Medical Device OEMs.
Skills & Requirements
Must-have
10+ years progressive engineering experience
Bachelor's degree in engineering field
FDA regulations and QMS knowledge
Lead regulatory inspections and audits
Manage non-conforming material processes
Develop test methods and validation protocols
Nice-to-have
Master's degree or Doctorate preferred
ISO and international standards awareness
Mentoring and coaching engineering teams
Global customer interaction experience
Continuous improvement methodology expertise
5 Sigma journey participation
Key Requirements
10+ years of engineering experience
Bachelor's degree in engineering
Knowledge of FDA regulations and ISO standards
Experience leading CAPA and complaint investigations