Auditor (Medical Devices)

Company Profile:

Monroe Consulting Group Vietnam is recruiting on behalf of a leading medical device manufacturer from the US seeking for a talented engineer with minimum 2 years of experience in an FDA regulated environment. The job is based in Ho Chi Minh City.

Job Summary:

The Auditor will be responsible for delivering internal audit following company’s SOP for suppliers and will have the opportunity to travel though-out Asia and the United States.

Job Responsibilities:

· Coordinate audit schedule with all vendors and interface with Medline internal QC/QA group and purchasing group.

· Travel to the supplier site and conduct on-site QSR audits and social accountability audits.

· Follow-up with the suppliers to address the problems identified during the initial audits.

· Publish audit reports in a timely manner.

· Other duties and projects as assigned.

·      Bachelor’s Degree in mechanical or packaging engineering

·      At least 2 years of experience in FDA compliance for medical device manufacturing

·      Familiar with FDA regulations, ASTM standards, QSR part 820, and ISO 13485

·      Able to travel though-out Asia and the United States

·      Fluent in English