Remote Medical Devices QMS Auditor – ISO13485 & MDSAP (Korea)

Bsi; Remote; ZAR 846 000 - 1 186 000; Full time

Job summary

A global standards organization seeks a Medical devices QMS auditor based in South Korea. The role involves assessing quality management systems, writing comprehensive reports, and leading assessment teams. Candidates must have a relevant bachelor's degree, extensive knowledge of ISO and EU medical device regulation, and a minimum of 5 years of experience. Proficiency in Korean and willingness to travel is essential. This position offers the chance to influence global standards and improve business performance.

Benefits

Extensive training

International travel opportunities

Supportive work environment

Qualifications

• Minimum 5 years of experience in quality management and technology management in medical devices.
• Native Korean speaker, JLPT N1 is a plus.
• Experience with animal tissue related medical devices is a plus.

Responsibilities

• Conduct assessments of quality management systems according to BSI requirements.
• Deliver assessment reports and provide clear corrective actions.
• Lead assessment teams and maintain quality service.

Skills

Quality management

ISO knowledge

Medical device regulation knowledge

Good communication skills

Time management skills

Public speaking

Education

Bachelor degree or above in medical device related field

Job description

A global standards organization seeks a Medical devices QMS auditor based in South Korea. The role involves assessing quality management systems, writing comprehensive reports, and leading assessment teams. Candidates must have a relevant bachelor's degree, extensive knowledge of ISO and EU medical device regulation, and a minimum of 5 years of experience. Proficiency in Korean and willingness to travel is essential. This position offers the chance to influence global standards and improve business performance.