QA Manager

MAIN RESPONSIBILITIES:

1. Manage the daily maintenance, internal audit and continuous improvement of ISO13485 QMS for Marketing Unit.

2. Lead the 0-1 establishment and implementation of the GMP for the China factory.

3. Establish end-to-end quality risk management, and oversee all types of quality deviations, process non-conformities, system anomalies and CAPA activities.

4. Manage quality reviews and controls for design transfer via cross-functional interface. Verify the completeness, accuracy and compliance of R&D outputs, production processes and quality specifica-tions, ensuring stable mass production quality and regulatory compliance.

5. Liaise with external testing institutions, certification bodies and regulatory authorities to ensure smooth completion of certifications and audits.

6. Conduct full-process quality control and supervision for the R&D and production of medical device projects throughout the entire product lifecycle.

7. Undertake other quality management tasks assigned by superiors and continuously optimize quality management processes and system efficiency.

8.other assignments from line manager

Requirements：

Bachelor Degree or Above medicine, pharmacy, and biological scientific or related discipline, related preferred.

-10 years working experience in quality assurance with GMP

Be able to read and write English and read English manuals.

knowledge in ISO13485 , GSP and CAPA would be highly preferred

Proficient in office software and have a certain basic knowledge of software