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 validation and capability studies
Incoming, In-Process and Final Inspection procedures
Root cause analysis
Nice-to-have
Customer success focus
Innovation and new approaches
Collaboration and teamwork
Respectful interaction
Open and honest communication
Positive, can-do attitude
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 certification (minimum)
Awareness of Domestic and International Regulations