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 ensure internal and external customer expectations are met by adhering to FDA regulations, QMS requirements, and company safety policies.
This role requires leading the generation of test method validation protocols and managing non-conforming material processes including root cause analysis.
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 environment
Experience with continuous improvement methodologies
Familiarity with Microsoft Office suite
Collaborative team player mindset
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)