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 act as a subject matter expert for SPC, FMEA, DOE, and process validation.
The position involves providing direction to Product Development teams to successfully launch new products into active production in a timely and cost-effective 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
SPC FMEA DOE process validation expertise
Bachelor's degree in engineering
3 years manufacturing experience
Nice-to-have
Excellent verbal and written communication skills
Strong data analysis in statistical packages
ERP system familiarity
Project management support capability
Subject matter expert for continuous improvement
Key Requirements
Minimum Bachelor's degree in engineering or equivalent
Minimum 3 years working experience in manufacturing environment