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 incumbent will lead regulatory inspections, audits, and investigations while ensuring compliance with FDA regulations and Quality Management Systems.
You will collaborate with a global team to drive continuous improvement projects, product transfers, and technical problem-solving initiatives.
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 or related field
FDA regulations and QMS knowledge
ISO and international regulatory standards
Root cause analysis and CAPA leadership
Process validation and capability studies
Nice-to-have
Master's degree or Doctorate preferred
Strong written and oral communication skills
Experience with global customer base
Ability to mentor and supervise engineers
Positive can-do attitude in high energy environment