Quality Engineer

Responsibilities

• Collect and review device history records (DHR/batch records) to ensure integrity, accuracy, and compliance with quality requirements
• Manage product release processes
• Lead non-conformity reviews, specifically focusing on issues impacting finished products, and support quality hold and disposition activities
• Participate in the development, review, and implementation tracking of product process validation and verification plans
• Act as an internal auditor for quality system and process audits, including report preparation and follow-up on corrective actions
• Support QA activities related to new product transfer projects

Requirements

• Bachelor’s degree or above, preferably in Medical Device, Mechanical Engineering, or a related field
• Minimum 3 years of quality control experience in a manufacturing environment
• Familiarity with ISO 13485 and 21 CFR 820 standards
• Knowledge of quality tools and basic statistical techniques, such as SPC
• Basic English communication, reading, and writing skills

Preferred Qualifications

• Previous GMP experience within the medical device industry

About the Company

Maquet (Suzhou) Co, Ltd. is part of Getinge, a global leader in medical technology. Getinge provides hospitals and life science institutions with products and solutions designed to improve clinical results and optimize workflows across intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing.