Quality Engineer II

We are seeking a Quality Engineer II with experience supporting electronic and electromechanical medical devices. This role is responsible for developing and implementing quality system processes to ensure compliance with FDA regulations, ISO standards, and internal quality requirements. You will support both new product development and sustaining engineering activities in a regulated environment.

• Support quality activities for new product development and existing products
• Develop inspection methods, test procedures, and quality documentation
• Perform failure analysis, defect investigations, and root cause analysis
• Design and implement quality control processes and statistical techniques
• Collaborate with Engineering, Manufacturing, and suppliers on quality issues
• Assist with SOP development, internal audits, and QMS compliance
• Ensure adherence to FDA, ISO 13485, and applicable regulatory standards

• Experience in Quality Engineering within the medical device industry
• Background supporting electronic or electromechanical devices preferred
• Experience with failure investigations, CAPA, and root cause analysis
• Knowledge of FDA regulations, ISO 13485, and quality system requirements
• Strong cross-functional communication and problem-solving skills