Our client is seeking a highly skilled and motivated Quality System Engineer to join our team in Malaysia. As a Quality System Engineer, you will be responsible for designing, implementing, and maintaining complex systems and solutions that support the company operations and growth. 

Job Responsibilities:

• Participate in the establishment, upgrade, maintenance, and day-to-day operation of the companys Quality Management System (QMS).
• Build, maintain, and continuously improve the QMS in line with FDA regulations and quality standards.
  Draft, revise, and periodically review QMS-related documents, and coordinate internal and external communication.
• Provide regular reports on the QMS performance.
• Carry out other tasks as assigned by the management.

Job Requirements:

• Bachelors degree or above, with at least 4 years of experience in sterile medical consumables; experience in the endoscopy field is a plus.
  
• Solid understanding of ISO 13485, GMP, MDD, and relevant regulations.
  
• Certified internal auditor with experience independently completing at least two full product lifecycle projects (from R&D to mass production).
  
• Strong communication and learning ability, team spirit, and good stress management skills.