Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product
Job Summary
Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product.
Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Lead plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Matching Summary
Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
Device History Records (DHR)
CAPA activities
Statistical Quality Control
Process Validation
Test Method Validation
Nice-to-have
Collaborate with cross-functional teams
Positive, can-do attitude
Calm demeanor
Subject matter expert
Key Requirements
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
15+ years of relevant experience (if education requirement not met)
6-Sigma Green Belt or Black Belt certification
Awareness of Domestic and International Regulations (ISO, QSR, MDD, etc.)