Sr.quality Assurance Engineer

Envista

Jiangsu, China
Product quality management
Process validation
New project transfer
Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards

Job Summary

  • Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards.
  • May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.
  • May lead audit and inspection preparation, resolution of audit and inspection findings.

Matching Summary

Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards.

Skills & Requirements

Must-have

  • product quality management
  • process validation
  • new project transfer
  • root cause analysis
  • CAPA tool

Nice-to-have

  • responsible and careful personality
  • good communication and teamwork skill

Key Requirements

  • Bachelor's degree or above
  • At least 5 years of working experience
  • experience with ISO13485
  • experience with China GMP
  • experience with QSR820 preferred
  • Understand safety regulations for active medical devices
  • Understand EMC requirements

Work Rights

Not specified

Tailored Resume

Cover Letter