Not specified (assumed to be on-site due to manufacturing environment).
Fda quality system regulations compliance
Iso 13485 standards knowledge
Spc fmea doe process validation
Integer is seeking a Quality Engineer III to ensure compliance with quality standards and improve product development processes in the medical device manufacturing sector. The ideal candidate will have a background in engineering, experience in quality management systems, and strong analytical skills
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
Match Score: 85
Integer is seeking a Quality Engineer III to ensure compliance with quality standards and improve product development processes in the medical device manufacturing sector. The ideal candidate will have a background in engineering, experience in quality management systems, and strong analytical skills.
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
Geometric tolerance expertise
Continuous improvement project leadership
Key Requirements
Minimum Bachelor's degree in engineering
3 years working experience in manufacturing environment