This role supports new product development and sustaining projects to ensure compliance with FDA, ISO 13485, and other global regulatory standards
Job Summary
This role supports new product development and sustaining projects to ensure compliance with FDA, ISO 13485, and other global regulatory standards.
The engineer will write validation protocols, analyze data using statistical tools like Six Sigma, and assist in corrective actions for quality issues.
Candidates must have a strong background in medical device regulations including GMP, QSR, and European Essential Requirements under the MDR.
Matching Summary
Match Score: 85
This role supports new product development and sustaining projects to ensure compliance with FDA, ISO 13485, and other global regulatory standards.
Skills & Requirements
Must-have
Bachelor's degree in related field
2-4 years quality or manufacturing experience
Medical device regulated industry experience
Process validation and verification skills
Statistical analysis tools (Six Sigma, SPC, DOE)
Design control and risk management knowledge
Nice-to-have
Master's degree preferred
ASQ certification desirable
GD&T concepts familiarity
Supplier audit support experience
Project management application skills
Key Requirements
Bachelor's degree required
2-4 years experience in medical device industry
Knowledge of GMP and QSR requirements
Experience with design control and V&V methodologies