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 a subject matter expert for SPC, FMEA, DOE, and process validation.
The position involves providing direction to the Product Development team to successfully launch new products into active production in a timely manner.
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 Quality System Regulations compliance
ISO 13485 standards knowledge
Statistical Process Control (SPC) expertise
FMEA and DOE methodology application
Process validation leadership
Supplier approval and qualification support
Nice-to-have
Excellent verbal and written communication skills
Project management support experience
ERP system familiarity
Geometric tolerance and mechanical drawing knowledge