Quality Specialist
Smith+Nephew is hiring a Quality Specialist in Shanghai, China. Level rates it ; you can apply on Smith+Nephew.
Level's read on this job
- Level rates this role Little AI ●○○○: aI is not part of the work.
- Level classes it as a mid-level role.
- Smith+Nephew has 346 other open roles on Level.
AI in this role
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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How we rate this
Quality Specialist at Smith+Nephew rates 36 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
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