Remote Medical Devices QMS Auditor (ISO13485/MDSAP)

BSI; Remote; ZAR 50 000 - 200 000; Full time

Job summary

A global business standards organization is looking for a Medical devices QMS auditor. This role involves assessing ISO quality management systems and medical device regulations at client sites in South Korea, preparing reports, and maintaining strong client relationships. Ideal candidates should have a Bachelor's degree, significant quality management experience in the medical device sector, and excellent communication skills. Opportunity for international travel exists.

Qualifications

• Minimum 5 years of quality management experience in medical devices.
• Native Korean speaking; JLPT N1 is a plus.
• Knowledge of EU medical device regulations.

Responsibilities

• Assess ISO 13485 QMS at client sites.
• Prepare reports and deliver findings.
• Lead assessment teams and maintain client relationships.

Skills

Quality management

ISO 13485 knowledge

Regulatory compliance

Communication skills

Public speaking

Education

Bachelor degree or above in medical device related field

Job description

A global business standards organization is looking for a Medical devices QMS auditor. This role involves assessing ISO quality management systems and medical device regulations at client sites in South Korea, preparing reports, and maintaining strong client relationships. Ideal candidates should have a Bachelor's degree, significant quality management experience in the medical device sector, and excellent communication skills. Opportunity for international travel exists.