Quality Specialist
On-siteShanghai, Shanghai, China
Job Summary
Ensure design transfer to manufacturing by collaborating with cross-functional teams and conduct product marketing releases on behalf of the legal manufacturer. Perform periodical manufacturing process audits to verify product and production process conformity against ISO 13485, local GMP, or overseas GMP inspection regulations. Lead product complaint investigations, driving cross-functional teams and suppliers to conduct root cause analyses, determine product impacts, and execute corrective actions in compliance with NMPA GMP and Smith-Nephew requirements. Prepare quality documentation, author or review CAPA and investigation reports, and maintain UDI data in the NMPA system. Support company initiatives related to the medical device production quality system, including the repair center.
Required Qualifications
- Bachelor's degree or higher in a relevant major including medical devices, biomedical engineering, mechanical engineering and electronics engineering
- Over 3 years working experience of QA position in MD manufacturing area
- Familiar medical device regulations: NMPA GMP, ISO 13485
- Fluent English both written and oral
Desired Qualifications
- Mechanical background, Design transfer experience are preferred
- Experience supporting internal and external audits (NMPA GMP, ISO 13485) are preferred
- Experience of MAH project is a plus
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