Quality Assurance Engineer

About the role

The Quality Assurance Engineer supports Medline's division by providing quality perspective on projects, ensuring compliance with company and international standards for medical devices.

Key responsibilities

• Ensure suppliers understand and follow Company and International standards, processes, and procedures.
• Perform in‑line and finished‑product verification according to ISO 13485/9001.
• Collaborate with QA and PM teams to set testing parameters and reduce product failures.
• Conduct process audits, identify improvement opportunities, and drive continuous improvement.
• Lead vendor projects focusing on design changes, quality performance, and monitoring critical products.
• Assist in root‑cause investigations, implement CAPAs, and work with US and China teams to resolve complaints and reduce rejections.

Required profile

• B.S. in Mechanical, Materials, Industrial Engineering or related medical‑device field.
• Minimum 3 years of engineering experience; project management preferred.
• Strong knowledge of ISO 13485 or ISO 9001 quality systems.
• Excellent written and verbal communication in English.
• Detail‑oriented with ability to travel frequently.

Required skills

• AutoCAD or SolidWorks
• Microsoft Word
• Microsoft Excel
• Adobe suite

What we offer

• Health insurance, life and disability coverage
• 401(k) contributions
• Paid time off
• Employee Assistance Program, Resource Groups, and Service Corps