QA Manager (Medical Devices)

Location: Shanghai, China; onsite

Company

A life sciences and healthcare organization developing solutions for biological research, vaccines, medicines, and cell and gene therapies.

What you will do

• Manage GSP-related policies and compliance affairs for medical devices in China.
• Ensure compliance with Shanghai MPA and Pudong Market Bureau requirements, including advertising and promotional material filings when needed.
• Support China localization projects from a quality perspective.
• Lead or contribute to post-market quality activities and internal and external audits.
• Drive continuous improvement through timely CAPA delivery and maintenance of the quality management system.
• Prepare and review Quality Agreements for commercial teams and customers.

Requirements

• Bachelor’s degree or higher in healthcare or life sciences, such as medical devices, chemistry, biopharma, or pharma.
• 5–8 years of quality assurance or quality engineering experience.
• Experience with GSP, GMP, and/or ISO 9001/13485 quality system requirements.
• Strong problem-solving skills and a high sense of responsibility.
• Fluent written and/or spoken English.

Nice to have

• Qualification as an internal auditor for ISO 9001 or ISO 13485.
• Fast learning ability and strong cross-functional communication and collaboration skills.

Culture & Benefits

• Work in a life sciences environment focused on tangible impact in human health.
• Comprehensive benefits supporting healthcare and paid time off.
• Collaboration with customers and teams solving complex science and technology challenges.