Medical Device Auditor (Active)

Key Responsibilities:

Perform onsite audits at manufacturer’s premises by evaluating their Quality Management Systems in accordance with the requirements of the MDR / IVDR, and other QMS certification schemes such as ISO 13485, ISO 9001 and MDSAP
Maintain customer communication as project leader for the allocated customers regarding auditing and certification, deal with clients’ queries relating to certification process including application reviews within acceptable time frames.
Take charge of pre and post audit tasks including preparation of audit documentation and audit package submission
Assist Sales personnel by providing technical advice to existing and prospective clients
Job Requirements:

At least bachelor’s degree with diploma in active medical device related major (e.g. Biomedical Engineering, Electronic Engineering, Automatic Control);
Have minimum 4 years of relevant experience in testing of medical device / design and development activities / process validation / application of process technology / service & maintenance in the medical device industry.
Have at least 2 years’ experience in Quality Management Systems environment (e.g. manufacturing, quality control, or research)
Qualified auditor for ISO 13485; experience with MDR / IVDR and/or MDSAP is a strong advantage
Clear and articulate presentation ability with excellent communication skills
High level of customer orientation and ability to manage challenging audit situations
Frequent travelling will be required within ASEAN, with occasional travel to other regions