Quality Assurance Engineer III

The Quality Assurance Engineer is responsible for supporting and improving product quality, manufacturing processes, and Quality Management System compliance within a regulated medical device environment.

What You Will Do

Assure quality system processes are in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device regulations. Provide advanced quality engineering support for manufacturing operations to ensure products meet established specifications, regulatory requirements, and quality standards.

Why It Might Be a Fit

Strong analytical and technical problem-solving skills, self-motivated, detail-oriented, and well-organized with excellent communication skills, both written and verbal.

Requirements

• Bachelor’s degree in engineering, biological science or a related technical field
• Minimum three-five years of quality engineering experience in a highlighted regulated environment, medical device preferred
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and medical device quality systems
• Experience with NCR/NMR, complaint investigations, validations, supplier quality, and audits
• Ability to read and interpret engineering drawings, specifications, and regulatory requirements
• Ability to work collaboratively with cross-functional team members
• Proficient with Microsoft Office and quality management software systems

Benefits

• Annual base salary
• Occasional domestic travel for supplier visits or audits