质量体系专员

Abbott

Hangzhou, China
Not specified
Iso13485 standard knowledge
Medical device qa experience
Internal auditor certificate
Abbott is seeking a Quality System Specialist in Hangzhou, China, to manage and enhance documentation systems within its quality assurance framework for medical devices. The role requires a strong background in quality management, familiarity with ISO standards, and proficiency in English, alongside relevant experience in the medical device industry

Job Summary

  • The role involves managing the company's documentation system to ensure all QA documents meet divisional, corporate, and regulatory requirements.
  • Candidates will support internal and external audit readiness activities, including training staff and tracking improvements for closure.
  • The position requires leading or participating in CAPA projects to ensure compliance and timeliness of records within electronic systems.

Matching Summary

Match Score: 85

Abbott is seeking a Quality System Specialist in Hangzhou, China, to manage and enhance documentation systems within its quality assurance framework for medical devices. The role requires a strong background in quality management, familiarity with ISO standards, and proficiency in English, alongside relevant experience in the medical device industry.

Skills & Requirements

Must-have

  • ISO13485 standard knowledge
  • Medical device QA experience
  • Internal auditor certificate
  • Fluent English communication
  • CAPA project management

Nice-to-have

  • Six Sigma root cause analysis
  • Statistical data analysis skills
  • Continuous improvement initiatives
  • Electronic system record handling

Key Requirements

  • Bachelor's degree in Engineering, Biology, Chemistry, Pharmacy, or related field
  • At least 3 years of medical device quality assurance experience
  • Quality management system internal auditor certificate
  • Proficiency in Word, Excel, and PowerPoint software

Work Rights

Not specified

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