Remote Medical Devices QMS Auditor (ISO13485/MDSAP)

BSI; Remote; ZAR 1 355 000 - 1 695 000; Full time

Job summary

A leading standards organization is seeking a Medical devices QMS auditor to conduct management system assessments according to ISO 13485. You will prepare detailed reports, manage client relationships, and ensure compliance with medical device regulations. The ideal candidate has at least 5 years of quality management experience and a strong background in the medical device sector. This role involves extensive travel, both domestic and international, to assess clients' systems and support their business development efforts.

Benefits

Training opportunities

Travel allowances

Flexible work arrangements

Qualifications

• Minimum 5 years experience in quality management for medical devices.
• Knowledge of ISO 13485 and EU medical device regulation is essential.
• Fluent in Korean; JLPT N1 is advantageous.

Responsibilities

• Conduct assessments of management systems per BSI requirements.
• Prepare detailed assessment reports and deliver findings.
• Lead assessment teams, ensuring quality service and relationships.

Skills

Quality management experience

Verbal and written communication skills

Public speaking skills

Business development skills

Education

Bachelor degree in medical device industry related major

Job description

A leading standards organization is seeking a Medical devices QMS auditor to conduct management system assessments according to ISO 13485. You will prepare detailed reports, manage client relationships, and ensure compliance with medical device regulations. The ideal candidate has at least 5 years of quality management experience and a strong background in the medical device sector. This role involves extensive travel, both domestic and international, to assess clients' systems and support their business development efforts.