The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive quality knowledge in extensive assignments
Job Summary
The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive quality knowledge in extensive assignments.
You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
As a subject matter expert, you are expected to mentor other engineers, supervise up to 5 direct reports, and drive continuous improvement projects across the organization.
Matching Summary
The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive quality knowledge in extensive assignments.
Skills & Requirements
Must-have
10+ years progressive engineering experience
FDA regulations and QMS knowledge
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
ISO and international standards awareness
Mentoring and supervising engineering teams
Global customer interaction capabilities
Continuous improvement methodology adoption
Key Requirements
Bachelor's degree in engineering or related technical field