This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry
Job Summary
This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry.
The successful candidate will lead regulatory inspections, manage non-conforming material processes, and drive continuous improvement projects across manufacturing operations.
You will serve as a coach and mentor for up to five direct reports while ensuring adherence to FDA regulations and company values.
Matching Summary
This role provides strategic quality guidance to support Integer's goals as a subject matter expert in the medical device industry.
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
Root cause analysis and CAPA leadership
Process validation and test method development
Nice-to-have
Master's degree or Doctorate preferred
Experience with global customer interactions
Strong written and oral communication skills
Ability to mentor and supervise engineers
Positive can-do attitude in high energy environment