Perform work involving general engineering methods and tools, utilizing advanced quality tools and concepts to resolve acute or chronic problems in the medical device industry
Job Summary
Perform work involving general engineering methods and tools, utilizing advanced quality tools and concepts to resolve acute or chronic problems in the medical device industry.
Support regulatory and agency inspections, audits, and investigations, while monitoring manufacturing for compliance and reviewing changes to product documentation.
The company offers a comprehensive benefits package with immediate eligibility, including medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching.
Matching Summary
Perform work involving general engineering methods and tools, utilizing advanced quality tools and concepts to resolve acute or chronic problems in the medical device industry.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
test method validations
process validations
non-conforming material disposition
Nice-to-have
collaborative team environment
positive can-do attitude
calm demeanor in high-energy environment
Manufacturing Excellence strategies
Key Requirements
Bachelor's degree in engineering or related field
3+ years relevant experience
7+ years relevant experience (if no degree)
Awareness of Domestic and International Regulations