Quality Engineer (Medical Devices)

TL;DR

Quality Engineer (Medical Devices): Ensuring product quality and regulatory compliance for life-saving medical technology with an accent on device history records, non-conformity review, and internal auditing. Focus on maintaining ISO 13485 and GMP standards, implementing statistical process control (SPC), and managing quality activities during new product transfers.

Location: Suzhou, China

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Collect and review device history records (DHR/batch records) to ensure integrity, accuracy, and compliance.
• Manage product release and handle quality holds for products released from the factory but not yet delivered.
• Lead non-conformity review processes, specifically focusing on issues impacting finished products.
• Conduct internal quality system and process audits, preparing reports and tracking improvement actions.
• Develop, review, and track process confirmation and validation master plans.
• Execute QA-related activities for new product transfer projects.

Requirements

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

Culture & Benefits

• Opportunity to develop personally and professionally within diverse, passionate teams.
• Role focused on making life-saving technology accessible to more people.
• Inclusive environment with reasonable accommodations available during the selection process.