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 and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
You are expected to collaborate with others, ask questions, and regularly check for understanding in support of your development as an engineer.
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 CAPA processes
Ability to lead test method validations
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude
Experience with continuous improvement projects
Calm demeanor in high-energy environments
Collaborative team player
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)