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 implementation of continuous improvement projects and act as a subject matter expert for SPC, FMEA, DOE, and process validation.
The position involves supporting supplier approval, managing corrective actions, and assisting with FDA and ISO inspections.
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 compliance knowledge
ISO 13485 standards expertise
SPC FMEA DOE process validation
Bachelor's degree in engineering
3 years manufacturing experience
Supplier audit and qualification
Nice-to-have
Excellent verbal communication skills
ERP system proficiency
Geometric tolerance knowledge
Continuous improvement leadership
Project management support skills
Key Requirements
Minimum Bachelor's degree in engineering
3 years working experience in manufacturing environment