The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards while actively participating in internal audits
Job Summary
The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards while actively participating in internal audits.
Candidates will lead continuous improvement projects and serve as subject matter experts for statistical process control, FMEA, and process validation.
The position involves directing the development of inspection methods, supporting supplier qualifications, and managing the disposition of discrepant materials.
Matching Summary
The role requires maintaining company compliance with FDA Quality System Regulations and ISO 13485 standards while actively participating in internal audits.
Skills & Requirements
Must-have
Bachelor's degree in engineering
3 years manufacturing experience
FDA QSR and ISO 13485 knowledge
Statistical analysis and SPC expertise
FMEA and DOE process validation
Nice-to-have
Excellent verbal and written communication
ERP system proficiency
Geometric tolerance knowledge
Project management support skills
Safety committee participation
Key Requirements
Minimum Bachelor's degree in engineering
3 years working experience in manufacturing environment