The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry
Job Summary
The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry.
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality, and monitor manufacturing of assigned products, assuring compliance with DMR.
Our total rewards program includes base salary, a cash-based incentive program, comprehensive benefits with immediate eligibility, and 80 hours of company designated holidays per year plus an annual allotment of paid time off.
Matching Summary
The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineer 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 process
Nice-to-have
collaborative team player
calm demeanor
positive can-do attitude
Manufacturing Excellence strategies
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 and Industry Standards