Not specified (assumed to be on-site based on job nature).
Fda quality system regulations compliance
Iso 13485 standards knowledge
Statistical packages and microsoft office
Integer is seeking a Quality Engineer III to ensure compliance with FDA Quality System Regulations and ISO 13485 standards, focusing on quality management, continuous improvement projects, and effective product development. The ideal candidate should possess a Bachelor's degree in engineering, a minimum of three years of experience in a manufacturing environment, preferably in medical devices, and strong analytical and communication 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 continuous improvement projects and act as a subject matter expert for SPC, FMEA, DOE, and process validation.
The position involves providing direction to the engineering group for product development launches and supporting supplier approval processes.
Matching Summary
Match Score: 75
Integer is seeking a Quality Engineer III to ensure compliance with FDA Quality System Regulations and ISO 13485 standards, focusing on quality management, continuous improvement projects, and effective product development. The ideal candidate should possess a Bachelor's degree in engineering, a minimum of three years of experience in a manufacturing environment, preferably in medical devices, and strong analytical and communication skills.
Skills & Requirements
Must-have
FDA Quality System Regulations compliance
ISO 13485 standards knowledge
Statistical packages and Microsoft Office
SPC FMEA DOE process validation
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