Bachelor's degree in engineering or technical field
Knowledge of fda regulations and iso standards
This role serves as a strategic authority providing quality guidance to support Integer's goals in the medical device and energy markets
Job Summary
This role serves as a strategic authority providing quality guidance to support Integer's goals in the medical device and energy markets.
The incumbent will lead regulatory agency inspections, manage non-conforming material processes, and drive continuous improvement projects across manufacturing operations.
Candidates must possess extensive engineering knowledge to resolve complex problems while mentoring up to five direct reports and ensuring adherence to QMS and safety requirements.
Matching Summary
Match Score: 85
This role serves as a strategic authority providing quality guidance to support Integer's goals in the medical device and energy markets.
Skills & Requirements
Must-have
10+ years progressive engineering experience
Bachelor's degree in engineering or technical field
Knowledge of FDA regulations and ISO standards
Experience leading regulatory inspections and audits
Expertise in CAPA, FMEA, and root cause analysis
Nice-to-have
Master's degree or Doctorate preferred
Experience with global customer base interaction
Strong coaching and mentorship capabilities
Ability to work independently and collaboratively
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
Familiarity with Domestic and International Regulations (ISO, QSR, UL)
Proven ability to lead product transfers and validation protocols