Qms Quality Engineer

Danaher UK

Suzhou, China
Iso 13485 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 medical device related quality management system and regulatory requirements

Job Summary

  • The scope of this position is to ensure the establishment, implementation, maintenance, and improvement of the quality management system to meet medical device related quality management system and regulatory requirements.
  • Responsible for daily quality system work, including maintaining the company's quality management system, ensuring compliance with system requirements, and monitoring system operation.
  • Responsible for the company's quality management system management review, internal and external audits, daily supervision and inspection, tracking the rectification of audit findings, recommendations, and improvement items, and the implementation of corrective/preventive actions.

Matching Summary

The scope of this position is to ensure the establishment, implementation, maintenance, and improvement of the quality management system to meet medical device related quality management system and regulatory requirements.

Skills & Requirements

Must-have

  • ISO 13485 compliance
  • China GMP compliance
  • Quality management system maintenance
  • Internal and external audits
  • CAPA system management

Nice-to-have

  • Cross-departmental collaboration
  • Continuous process improvement
  • Employee quality awareness training
  • Effective communication at all levels

Key Requirements

  • Experience with medical device regulations
  • Experience with GMP requirements
  • Experience with quality system documentation
  • Experience with CAPA processes

Work Rights

Not specified

Tailored Resume

Cover Letter