Perform work involving general engineering methods and advanced quality tools to resolve acute or chronic problems, ensuring customer expectations are met or exceeded
Job Summary
Perform work involving general engineering methods and advanced quality tools to resolve acute or chronic problems, ensuring customer expectations are met or exceeded.
Support regulatory and agency inspections, monitor manufacturing for compliance, and review changes to product documentation while participating in continuous improvement projects.
Lead the generation of test method validation protocols, develop inspection techniques, and manage non-conforming material processes, including complaint investigations and CAPA activities.
Matching Summary
Perform work involving general engineering methods and advanced quality tools to resolve acute or chronic problems, ensuring customer expectations are met or exceeded.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
Test method validation protocols
Non-conforming material disposition
Root cause analysis
Nice-to-have
Collaborative team environment
Positive can-do attitude
Calm demeanor in high-energy environment
Continuous improvement mindset
Key Requirements
Bachelor's degree in engineering or related field
3 years relevant experience
7+ years relevant experience (if education requirement not met)
Awareness of Domestic and International Regulations