Qms Quality Engineer

Danaher

Suzhou, China
Iso13485 compliance
China gmp compliance
Quality management system maintenance
The scope of this position is to ensure the establishment, implementation, maintenance, and improvement of the quality management system to meet relevant quality management system and regulatory requirements for medical devices, such as China GMP and ISO13485

Job Summary

  • The scope of this position is to ensure the establishment, implementation, maintenance, and improvement of the quality management system to meet relevant quality management system and regulatory requirements for medical devices, such as China GMP and ISO13485.
  • Responsible for the daily work of the quality system, including maintaining the company's quality management system, ensuring compliance with system requirements, and monitoring system operation.
  • Collaborate across departments to promote the implementation of medical device regulations and GMP requirements within the company and lead process optimization for the Suzhou site to remain consistent with headquarters' requirements.

Matching Summary

The scope of this position is to ensure the establishment, implementation, maintenance, and improvement of the quality management system to meet relevant quality management system and regulatory requirements for medical devices, such as China GMP and ISO13485.

Skills & Requirements

Must-have

  • ISO13485 compliance
  • China GMP compliance
  • Quality management system maintenance
  • Internal and external audits
  • CAPA system management

Nice-to-have

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

Key Requirements

  • Medical device regulations
  • Quality management system
  • Internal audits
  • External audits
  • CAPA system

Work Rights

Not specified

Tailored Resume

Cover Letter