Job Title

Medical Device Auditor

Location

Busan, Korea

About COMPANY

International organization with excellent reputation, specializing in testing, inspection, and certification services. With a long-standing presence in Korea, it works across various industries including manufacturing, energy, and healthcare—helping clients align with global standards for quality, safety, and regulatory compliance.

Main Responsibilities

·Performing on-site audits at client facilities, including site tour, document review, worker/management interviews etc that required to complete audits

·Analyzing audit findings and compiling detailed audit reports identifying areas of compliance and non-compliance.

·Providing recommendations for corrective actions to address non-conformances.

·Writing and maintaining audit documentation and records in accordance with ISO 13485, CE MDR requirements and the company’s standard.

·Recommendation to be suggested for continuous improvement of clients.

·Staying up-to-date on the latest Medical Device Regulations as well as ISO 13485 standard, protocols, and industry best practices.

·Complete mandatory trainings from the global group.

Key Requirements

·Bachelor’s degree (e.g. Medical, Science, Technology, or Engineering fields)

·Career background of more than 4 years in relevant field such as the Medical device industry ( Quality Assurance, Quality Control, Regulatory Affairs, Design& Development)

·Completion of at least 40 hours of ISO 9001 and ISO 13485 auditor training courses from an accredited auditor training institution

· Preference given to those who have completed at least 16 hours of Risk Management Training (ISO 14971/ TR24971)

Contact

Matthew Kim, Perm Consultant

+82.2.6200.9788 / +82 10 5293 0716