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 act as subject matter experts for statistical process control, failure mode analysis, 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
FDA QSR and ISO 13485 compliance
Statistical analysis with SPC FMEA DOE
Bachelor's degree in engineering
3 years manufacturing experience
Supplier approval and qualification
Nice-to-have
Excellent verbal and written communication
Project management support skills
ERP system knowledge
Geometric tolerance expertise
Safety committee participation
Key Requirements
Bachelor's degree in engineering or equivalent
Minimum 3 years manufacturing environment experience