As a Medical Device Auditor, you’ll travel to medical device manufacturers across APAC to assess their ISO 13485 quality management system and ensure patient safety and regulatory compliance
Job Summary
As a Medical Device Auditor, you’ll travel to medical device manufacturers across APAC to assess their ISO 13485 quality management system and ensure patient safety and regulatory compliance.
In the first six months, you will receive training in ISO 13485 Lead Auditor, MDSAP, and MDR, progressing from observing audits to conducting them independently both onsite and remotely.
BSI is a global business improvement and standards company committed to creating positive change for people and the planet, fostering a diverse and inclusive workplace.
Matching Summary
As a Medical Device Auditor, you’ll travel to medical device manufacturers across APAC to assess their ISO 13485 quality management system and ensure patient safety and regulatory compliance.
Skills & Requirements
Must-have
ISO 13485 quality management system auditing
Medical device manufacturing audit experience
Frequent travel across APAC region
Fluent English and Chinese communication
Rubber medical device technology expertise
Nice-to-have
Resilience and adaptability
Advocate for ISO 13485 standards
Homebased audit work capability
Key Requirements
4+ years accountable for medical device design, test, or manufacture
Degree in relevant discipline (e.g. chemistry, biology, material science)
2+ years experience with Quality Management Systems