Quality Engineer

About the role

The Quality Engineer supports Medline's medical‑device divisions by providing quality‑focused guidance to internal teams and external suppliers. The role ensures compliance with company and international standards while driving continuous improvement across product design, production, and complaint handling.

Key responsibilities

• Communicate company and international quality standards to suppliers for various medical devices.
• Perform in‑line and finished‑product verification according to ISO 13485/ISO 9001.
• Collaborate with QA and Project Management to define testing parameters that minimize product failures.
• Conduct process audits and identify opportunities for improvement in process, production, and quality control.
• Lead vendor projects from a quality perspective, focusing on design changes, performance improvement, and monitoring of critical products.
• Assist US corporate office and Chinese QC teams in root‑cause investigations, CAPA implementation, and reduction of customer complaints.
• Work with suppliers to reduce product rejections, validate production parameters, and document improvements.

Required profile

• B.S. in Mechanical, Materials, Industrial, or related medical‑device engineering field.
• Minimum 3 years of engineering experience; project‑management experience preferred.
• Strong knowledge of quality system requirements (ISO 13485 or ISO 9001).
• Excellent written and verbal communication in English.
• Detail‑oriented with a sense of urgency and ability to handle special projects.

Required skills

• Proficiency with AutoCAD or SolidWorks.
• Advanced MS Word and MS Excel skills.
• Experience using Adobe software.