3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry
Job Summary
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
You will support regulatory inspections, monitor manufacturing compliance with DMR, and ensure complete Device History Records are maintained.
You will lead the generation of protocols for test method validations and manage non-conforming material dispositions to prevent re-occurrence.
Matching Summary
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of FDA regulations and ISO standards
Experience with QMS and CAPA processes
Ability to lead test method validations
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environment
Experience with continuous improvement methodologies
Familiarity with 5S and visual controls
Calm demeanor under pressure
Key Requirements
Bachelor's degree in engineering or related field
Minimum 3 years relevant experience
Awareness of domestic and international regulations (ISO, QSR, UL)