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, company policies, and Quality Management Systems.
This role requires leading test method validations, managing non-conforming material processes, and supporting regulatory inspections and audits.
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 Device History Records
Ability to lead CAPA and complaint investigations
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
3+ years relevant experience
Knowledge of Domestic and International Regulations
US citizenship not explicitly required but US applicants noted