APAC ISO13485 Medical Device Auditor (Remote/Travel)

BSI; Malaysia; Hybrid; MYR 70,000 - 90,000; Full time

Job summary

BSI is seeking a Medical Device Auditor to join our team in Malaysia. This role involves extensive travel across APAC to assess manufacturers’ ISO 13485 quality management systems, ensuring compliance with regulatory standards and enhancing patient safety.

Applicants should have a strong background in latex/rubber technology and a degree in a relevant field, coupled with experience in quality management systems. Fluency in English and Chinese is mandatory. Join us to make a significant impact on healthcare quality and compliance!

Qualifications

• At least 4 years of experience in medical device design, testing or manufacture.
• 2 years of experience in a Quality Management System.
• Ability to travel frequently across the APAC region.

Responsibilities

• Conduct audits at medical device manufacturers in APAC.
• Write reports and manage audit schedules.
• Advocate for the ISO 13485 APAC Delivery Team.

Skills

Background in latex/rubber technology

Fluent in English

Fluent in Chinese

Education

Degree in a relevant discipline

Job description

BSI is seeking a Medical Device Auditor to join our team in Malaysia. This role involves extensive travel across APAC to assess manufacturers’ ISO 13485 quality management systems, ensuring compliance with regulatory standards and enhancing patient safety.

Applicants should have a strong background in latex/rubber technology and a degree in a relevant field, coupled with experience in quality management systems. Fluency in English and Chinese is mandatory. Join us to make a significant impact on healthcare quality and compliance!