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 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
Bachelor's degree in engineering
3 years manufacturing experience
Nice-to-have
Excellent verbal and written communication
Strong statistical analysis skills
ERP system familiarity
Continuous improvement project leadership
Supplier audit and qualification support
Key Requirements
Bachelor's degree in engineering or equivalent
Minimum 3 years working experience in manufacturing environment