Quality Systems Engineer 2

The Quality Systems Engineer (QSE) plays a key role in sustaining and improving the company’s Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements.

Requirements

• Maintain and continuously improve core QMS processes including CAPA, Change Control, Document Control, Training, and Management Review.
• Serve as a subject matter expert (SME) for Quality System processes, providing guidance to multi-functional teams.
• Develop, implement, and maintain key performance indicators (KPIs) and quality metrics to drive visibility and continuous improvement.
• Lead the end-to-end CAPA process, including root cause analysis, effectiveness checks, and closure.
• Oversee the Change Control process to ensure effective evaluation, risk assessment, and implementation of changes.
• Find opportunities to streamline QMS processes, improve compliance efficiency, and enhance usability of quality systems.
• Support internal audits and regulatory inspections as a process owner or SME.
• Contribute to the development and rollout of digital tools or automation supporting QMS improvements.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Four Day Work Week