• Perform audit schemes such as <ISO13485, IS015378, ISO 9001 and other related medical device directives>.
• Follow and ensure timely completion of audit reports/surveillance.
• Develop and review audit methodologies for accreditation compliance
• Interact and provide support for other departments in both local & regional level to ensure on the day-to-day audit
execution going on smooth manner.
• Other audit related works assigned by reporting officer.
• Minimum Bachelor’s Degree in Biotechnology, Chemistry, Pharmaceutical, or any other similar engineer based major.
• Minimum 2-3 years of working experience as Auditor in Medical Device or 5 years of working experience in QA/QC, Production, R&D, Laboratory at Medical device manufacturers
• Good English proficiency covering all skills in reading, writing, speaking.
• Having ISO13485, IS015378 qualified audit background from international certification body is a good advantage.
• Experience in conducting audits, implementation and maintenance of management systems is also advantageous
• A result – oriented team player is highly required.
• A logical thought thinker with good presentation skill will be also preferable.
• Can be able to take regular business travel (domestic & overseas)