SUMMARY

Join a quality-focused medical manufacturing environment where you will play a key role in maintaining and improving product quality, regulatory compliance, and quality system effectiveness. This position offers the opportunity to work cross-functionally with engineering, operations, suppliers, and leadership while supporting new product development and continuous improvement initiatives. The Quality Engineer serves as a subject matter expert for quality processes, supplier quality, and regulatory compliance.

RESPONSIBILITIES

• Support, maintain, and improve the Quality Management System (QMS) in compliance with FDA, ISO 13485, MDSAP, and other applicable regulatory standards.
• Develop, review, and maintain quality documentation including SOPs, protocols, reports, validation documents, quality plans, and work instructions.
• Investigate product, process, and supp...