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 and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
You are expected to collaborate with others in the exchange of information 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 or related field
3 years relevant experience in quality engineering
Knowledge of FDA regulations and ISO standards
Experience with Quality Management Systems (QMS)
Ability to lead test method validations and protocols
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environments
Experience with continuous improvement methodologies
Familiarity with Microsoft Office suite
Collaborative team player mindset
Key Requirements
Bachelor's degree in engineering
3+ years relevant experience
Awareness of Domestic and International Regulations