Medical Device (Regulatory Systems) Auditor (Medical & Health Service)

Tasks/Aufgaben

We are currently looking for a Medical Device Auditor to join our Medical and Health Service team! You will be performing the audit for medical device manufacturers and ensuring that their Quality Management System (QMS) complies with Medical Devices including the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Devices Regulation (IVDR) and other QMS certification scheme, where applicable.

We welcome experts from different medical device industries!

For example:

IVD (in-vitro diagnostics) instrumentation and / or reagents

Active devices: active non-implantable surgical devices (Cryoablation, High frequency surgery, High-frequency generator, High-frequency instruments, ablation generators, suction pumps for blood), standalone software, Active Endoscopes, and etc

Qualifications/Qualifikationen

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

Assist Sales personnel by providing technical advice to existing and prospective clients

Deal with clients queries relating to certification process including application reviews within acceptable time frames as a project manager

Take charge of pre and post audit tasks including preparation of audit documentation and audit package submission

Further Information

Key Requirements:

Bachelor s degree in Electrical / Biomedical Engineering, Biomedical Science, Pharmaceutical, Chemical Engineering, Chemical Science, Biotechnology or relevant Sciences

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

Clear and articulate presentation ability with excellent communication skills

Travelling will be required within ASEAN, with occasional travel to USA and Europe

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