QA Specialist
Cytiva · Xian de Tonglu
Job description
About the role
Cytiva is seeking a QA Specialist to support quality assurance activities across its manufacturing sites. The role focuses on document control, training management, and handling internal quality issues to ensure compliance with medical‑device standards.
Key responsibilities
- Manage QA document control and site‑wide quality training, including the Cytiva learning system.
- Assist the QA team with internal and external audits, non‑conformance workflow, CAPA procedures, and change‑control management.
- Support manufacturing and CHU teams in addressing internal quality issues and customer complaints.
- Perform additional tasks assigned by the QA manager.
Required profile
- Bachelor’s degree or higher in a manufacturing‑related discipline.
- 2–3 years of experience in quality assurance and quality management systems.
- Familiarity with ISO 9001, ISO 13485, and other medical‑device quality system requirements.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) and basic English communication skills (CET‑4 or above).
- Experience with continuous improvement, CAPA processes, QC 7 tools, and Lean Six Sigma.
- Strong judgment, organizational coordination, and a sense of responsibility.
Required skills
- ISO 9001
- ISO 13485
- CAPA management
- Change control
- Document control systems
- QC 7 tools
- Lean Six Sigma
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
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Cytiva
Xian de Tonglu