Key Responsibilities:

• Quality System Management:

Develop and maintain a robust quality system to ensure regulatory compliance and continuous improvement.

1. Coordinate documentation management to ensure the efficiency of the quality system.

Conduct regulatory intelligence to monitor and act on relevant laws and standards.

• Quality Assurance:

Manage quality control functions and operational permissions of computer information systems.

1. Review and dynamically manage the qualifications of medical device suppliers, products, and purchasers.

Confirm and supervise the handling of non-conforming medical devices.

1. Coordinate the verification and calibration of relevant facilities and equipment.

Implement UDI to ensure medical device traceability.

• Post-Market Surveillance:

Investigate, handle, and report medical device quality complaints and incidents.

1. Manage medical device recalls and quality safety risk consultations.

Collect and report adverse events related to medical devices.

Qualifications:

• Bachelor’s degree in medical device, life science, chemistry, or a closely related field.
• Over 5 years of professional experience in quality management within the medical device industry.
• In-depth knowledge of GSP, ISO 13485 regulations.
• Proficient in English (both oral and written).
• Demonstrated ability to manage people with strong interpersonal skills for collaborating across teams and working with interested parties.

Join us on this outstanding journey and contribute to our mission of delivering world-class quality in medical device manufacturing. Apply your skills and experience to help us achieve flawless execution and compliance!