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 lead the generation and completion of protocols for test method validations and interface with Manufacturing Engineers to review processes.
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 CAPA and root cause analysis
Proficiency in creating test methods and protocols
Nice-to-have
Strong written and oral communication skills
Ability to work independently and collaboratively
Positive can-do attitude in high-energy environments
Familiarity with Microsoft Office suite
Experience with continuous improvement methodologies
Key Requirements
Minimum Bachelor's degree in engineering
3+ years relevant experience (or 7+ without degree)
Awareness of Domestic and International Regulations (ISO, QSR, UL)