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Shines BioTech

Quality Assurance Specialist

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Quality Assurance Specialist

Quality· Shanghai· Full-time

Placeholder QA role description.

Responsibilities

  1. Maintain the QMS in compliance with ISO 13485
  2. Review batch records and release finished goods
  3. Lead internal audits and CAPA follow-up

Requirements

  1. 3+ years in medical device QA
  2. Working knowledge of ISO 13485 / GMP
  3. Auditor certification is a plus