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.
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.
· Coordinate audit schedule with all vendors and interface with 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