This role provides strategic quality guidance to support Integer's goals as a subject matter expert in medical device manufacturing
Job Summary
This role provides strategic quality guidance to support Integer's goals as a subject matter expert in medical device manufacturing.
The successful candidate will lead regulatory inspections, manage non-conforming materials, and ensure compliance with FDA regulations and Quality Management Systems.
You will mentor up to 4-5 direct reports while collaborating with global customers to drive product transfers and continuous improvement initiatives.
Matching Summary
This role provides strategic quality guidance to support Integer's goals as a subject matter expert in medical device manufacturing.
Skills & Requirements
Must-have
10+ years progressive engineering experience
Bachelor's degree in engineering field
FDA regulations and QMS knowledge
ISO and international standards awareness
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
Experience with 5 Sigma initiatives
Strong written and oral communication skills
Ability to work independently and collaboratively
Positive can-do attitude in high energy environment
Experience leading continuous improvement projects