Integer is seeking a Principal Quality Engineer to provide strategic quality leadership and guidance in the medical device manufacturing sector. The ideal candidate will have extensive engineering experience, a strong understanding of quality systems, and a commitment to fostering a culture of excellence and collaboration
Job Summary
The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive and diversified quality knowledge.
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 solve unique and complex problems with a broad impact on the business while mentoring up to five direct reports.
Matching Summary
Match Score: 85
Integer is seeking a Principal Quality Engineer to provide strategic quality leadership and guidance in the medical device manufacturing sector. The ideal candidate will have extensive engineering experience, a strong understanding of quality systems, and a commitment to fostering a culture of excellence and collaboration.
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, UL, MDD, TGA standards awareness
Strong written and oral communication skills
Experience with global customer base
Ability to mentor and supervise engineers
Key Requirements
Bachelor's degree in engineering or related technical field
10+ years of progressive engineering experience
Knowledge of FDA regulations and Quality Management Systems
Experience leading CAPA activities and root cause analysis