QA Specialist (Medical Devices)

Location: Tonglu, Zhejiang, China; onsite

Company

hirify.global provides technologies and services that support the development and manufacture of therapeutics and is part of Danaher.

What you will do

• Manage QA document control and site quality training through the hirify.global learning system.
• Support internal and external audits, nonconformance workflows, CAPA procedures, and change control management.
• Support manufacturing and CHU teams in resolving internal quality issues and customer complaints.
• Carry out additional quality assurance activities assigned by the QA Manager.

Requirements

• Bachelor’s degree or above in a manufacturing-related field.
• 2–3 years of experience in quality assurance and quality management systems.
• Knowledge of manufacturing enterprise processes and ISO 9001, ISO 13485, and other medical device quality system requirements.
• Experience with continuous improvement and CAPA processes.
• Proficiency in Word, Excel, PowerPoint, and similar office software.
• CET-4 or above and good English communication skills required.

Nice to have

• Proficiency with QC 7 tools and Lean Six Sigma.
• Strong judgment, organizational coordination, communication skills, and sense of responsibility.

Culture & Benefits

• Work within a global life sciences organization serving customers across 40 countries.
• Contribute to technologies supporting biological research, vaccines, biologic drugs, and cell and gene therapies.
• Collaborate with hirify.global and Danaher teams focused on solving complex scientific and manufacturing challenges.