Bachelor's degree in engineering or technical field
Fda regulations and qms knowledge
The primary purpose of this position is to provide strategic quality guidance that supports Integer's goals while applying intensive and diversified quality knowledge
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 mentor other engineers, manage continuous improvement projects, and ensure adherence to FDA regulations and Quality Management Systems.
Matching 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.
Skills & Requirements
Must-have
10+ years progressive engineering experience
Bachelor's degree in engineering or technical field
FDA regulations and QMS knowledge
Lead regulatory inspections and audits
Manage non-conforming material processes
Develop test method 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
Positive can-do attitude in high energy environment