Quality Specialist

Roles and Responsibilities:

1. Ensure design transfer to manufacturing successfully process by working together with cross-function team.

2. Conduct product marketing release on behalf of legal manufacturer.

3. Ensure production comply with ISO 13485, local GMP or oversea GMP inspection regulation, NMPA registration QMS requirements, act as SME in production quality management.

4. Perform periodical manufacturing process audit to ensure product and production process conformity.

5. Work with cross-function team on medical devices supplier evaluation, engineering changes, NC and CAPA approvals.

6. Lead and drive product complaint investigation process, lead cross-function team of Smith-Nephew Shanghai as well as drive supplier to conduct root cause analysis, determine product impact, corrective action activities for identified quality issues and ensure timely handling the investigation and conclusion in compliance with NMPA GMP, ISO13485 and Smith-Nephew requirements.

7. Prepare quality documentation and reports, author or review of CAPA, investigation reports, test reports or any submissions for internal or external stakeholders.

8. Support other company initiatives related to medical device production quality system, such as repair center.

9. Perform UDI data maintenance in NMPA system.

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
• 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
• Fluent English both written and oral

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