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, Quality Management Systems, and company policies.
You will lead the generation of protocols for test method validations and participate in plant CAPA activities to analyze data trends and root causes.
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 in high-energy environment
Experience with continuous improvement methodologies
Familiarity with 5S and visual controls
Collaborative team player mindset
Key Requirements
Minimum Bachelor's degree in engineering or related field
3 years of relevant experience (or 7+ without degree)
Awareness of domestic and international regulations (ISO, QSR, UL)