The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields to ensure customer expectations are met or exceeded
Job Summary
The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields to ensure customer expectations are met or exceeded.
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
You will lead plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Matching Summary
The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields to ensure customer expectations are met or exceeded.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
Test method validations
Non-conforming material process
Root cause analysis
Statistical quality control
Nice-to-have
Collaborate with cross-functional teams
Positive, can-do attitude
Calm demeanor in high-energy environment
Passionately pursuing excellence
Reaching for great achievement
Key Requirements
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
6-Sigma Green Belt minimum
Awareness of Domestic and International Regulations