The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals as a subject matter expert
Job Summary
The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals as a subject matter expert.
You will lead regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
As a recognized leader, you may supervise up to 4 to 5 engineering direct reports while serving as a coach and mentor for other engineers.
Matching Summary
The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals as a subject matter expert.
Skills & Requirements
Must-have
10+ years progressive engineering experience
Bachelor's degree in engineering or related field
FDA regulations and QMS knowledge
ISO and QSR industry standards awareness
Lead regulatory inspections and audits
Manage non-conforming material processes
Develop test method validation protocols
Nice-to-have
Master's degree or Doctorate preferred
Experience with global customer base
Mentoring and coaching engineering teams
Continuous improvement methodologies
Strong written and oral communication skills
Ability to work independently and collaboratively
Key Requirements
10+ years of progressive engineering experience
Bachelor's degree in engineering required
Knowledge of FDA regulations and ISO standards
Experience leading CAPA and complaint investigations