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)
Process Improvement Projects
Test Method Validation
Non-Conforming Material Process
CAPA activities
Statistical Quality Control
Nice-to-have
Customer success focus
Innovation and new approaches
Collaboration and teamwork
Respectful interaction
Open and honest communication
Integrity and doing things right
Calm demeanor in changing environment
Positive, can-do attitude
Key Requirements
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
6-Sigma Green Belt (Black Belt preferred)
Awareness of Domestic and International Regulations
Proficiency in Microsoft Office
Independent and collaborative work ability
Strong technical aptitude
Competencies in written and oral English communications