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)
FDA regulations
Device History Records (DHR)
Bill of Materials (BOMs) review
process validations
test method validations
Non-conforming material disposition
Nice-to-have
passionately pursuing excellence
reaching for the next great achievement
calm demeanor
positive, can-do attitude
failure is not an option
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 (minimum)
Awareness of Domestic and International Regulations