This role provides strategic quality guidance as a subject matter expert to support Integer's goals in the medical device industry
Job Summary
This role provides strategic quality guidance as a subject matter expert to support Integer's goals in the medical device industry.
The incumbent will lead regulatory inspections, manage non-conforming material processes, and drive continuous improvement projects across manufacturing operations.
Candidates must possess over a decade of engineering experience and demonstrate the ability to work independently while collaborating with cross-functional teams.
Matching Summary
This role provides strategic quality guidance as a subject matter expert to support Integer's goals 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 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
Key Requirements
10+ years of progressive engineering experience
Bachelor's degree in engineering or related technical field
Knowledge of FDA regulations and Quality Management Systems