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 Device Master Records, and lead the generation of test method validation protocols.
This role requires embedding a culture of quality by ensuring adherence to Quality Management Systems and leading corrective action investigations for non-conforming materials.
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
3 years relevant experience
Knowledge of FDA regulations and ISO standards
Experience with QMS and DMR compliance
Root cause analysis and CAPA management
Nice-to-have
Continuous improvement project leadership
Strong written and oral communication skills
Ability to work independently and collaboratively
Positive can-do attitude in high-energy environment
Experience with process validation studies
Key Requirements
Bachelor's degree in engineering or related field
Minimum 3 years of relevant experience
Awareness of domestic and international regulations (ISO, QSR, UL)