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 the implementation of continuous improvement projects and serve as a subject matter expert for statistical process control and design controls.
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
SPC, FMEA, DOE expertise
Process validation and design control
Nice-to-have
Excellent verbal communication skills
Project management support experience
ERP system familiarity
Safety committee participation
Continuous improvement leadership
Key Requirements
Minimum Bachelor's degree in engineering
3+ years in medical device manufacturing
Strong data analysis skills in statistical packages