Remote Medical Devices QMS Auditor — ISO13485

Bsi; Cape Town; Remote; ZAR 588 000 - 824 000; Full time

Job summary

A leading standards organization is seeking a Medical devices QMS auditor to perform audits and assessments in the South Korea region. You will be responsible for conducting evaluations according to ISO standards and medical device regulations, preparing reports, and leading assessment teams. The role requires a Bachelor's degree and at least 5 years of experience in quality management within the medical device industry. Proficiency in Korean is essential.

Qualifications

• Minimum 5 years quality management experience in the fields of Medical devices.
• Native Korean speaking; JLPT N1 is a plus.
• Knowledge of ISO and EU medical device regulation.

Responsibilities

• Undertake management system assessments according to BSI standards.
• Prepare and deliver assessment reports to clients.
• Lead assessment teams ensuring quality service.

Skills

Quality management

Medical device regulation

Communication skills

Commercial understanding

Problem-solving

Education

Bachelor's degree in a relevant field

Job description

A leading standards organization is seeking a Medical devices QMS auditor to perform audits and assessments in the South Korea region. You will be responsible for conducting evaluations according to ISO standards and medical device regulations, preparing reports, and leading assessment teams. The role requires a Bachelor's degree and at least 5 years of experience in quality management within the medical device industry. Proficiency in Korean is essential.