Qms Quality Engineer

Danaher

Not specified (potentially hybrid or onsite)
Quality management system maintenance
Iso13485 and china gmp compliance
Internal and external audit management
Danaher is seeking a QMS Quality Engineer to ensure the establishment, implementation, maintenance, and improvement of the quality management system in compliance with medical device regulations such as China GMP and ISO 13485. The role involves daily management of the quality system, collaboration across departments, and participation in audits and training to uphold quality standards

Job Summary

  • The scope of this position is to ensure the establishment, implementation, maintenance, and improvement of the quality management system to ensure the company system complies with medical device related quality management system and regulatory requirements.
  • Responsible for daily quality system work, including maintaining the company's quality management system, satisfying system requirements, and monitoring system operation.
  • Lead process optimization for Leiduo Suzhou to ensure consistency with headquarters' requirements.

Matching Summary

Match Score: 85

Danaher is seeking a QMS Quality Engineer to ensure the establishment, implementation, maintenance, and improvement of the quality management system in compliance with medical device regulations such as China GMP and ISO 13485. The role involves daily management of the quality system, collaboration across departments, and participation in audits and training to uphold quality standards.

Skills & Requirements

Must-have

  • Quality Management System maintenance
  • ISO13485 and China GMP compliance
  • Internal and external audit management
  • CAPA system management
  • Process optimization and improvement

Nice-to-have

  • Cross-departmental collaboration
  • Employee quality awareness training
  • Continuous improvement culture

Key Requirements

  • Experience with ISO13485
  • Experience with China GMP
  • Quality Management System experience

Work Rights

Not specified

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