Medical Device Auditor (Non-Active Devices):

We are currently looking for a Medical Device Auditor (Non-Active Devices) to join our Medical and Health Service team! You will be performing the certification and auditing activities across the Non-Active Medical Device Manufacturers and Service Providers. In this role, you will assess the Quality Management Systems (QMS) of these organizations for compliance with the requirements of Medical Devices Standards and Regulation including Medical Device Regulation (MDR) / In-Vitro Diagnostic Device Regulation (IVDR), Medical Device Single Audit Program (MDSAP), ISO 13485 and other QMS certification, where applicable.

We welcome experts from different medical device and healthcare related industries!

For example:

Non-Active Devices: Non-active osteo and orthopaedic implants; non-active dental implants and dental materials; Non-active implantable solutions and ophthalmic implants; Non-active non-implantable devices for anaesthesia, emergency and intensive care; Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis; Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools; Non-active non-implantable devices for wound and skin care; Non-active non-implantable orthopaedic and rehabilitation devices; Non-active non-implantable ophthalmologic devices; Non-active non-implantable diagnostic devices; Non-active non-implantable instruments; Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases; Non-active non-implantable devices for disinfecting, cleaning and rinsing, and etc.

Key Responsibilities:

• Conduct 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 Handler / Customer Specialist for the allocated client’s queries relating to certification process including application reviews within acceptable time frames
• Take charge of pre and post audit activities 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 related to Non-Active Medical Devices related major e.g. Biomedical Engineering, Clinical Laboratory Science, Pharmacy / Pharmaceutical Sciences, Mechanical or Materials Engineering (especially for implants/devices), Chemical Engineering (for biomaterials, coatings, polymers), Life Sciences (e.g. Biology, Microbiology, Biotechnology)
• Have minimum 4 years of relevant experience in Production, QA, Testing of Medical Devices, Design and Development Activities / Process Validation / Application of Process Technologies in the Medical Device Industries
• Have at least 2 years’ experience in Quality Management Systems’ environment (e.g. Manufacturing, Quality Control, or research)
• Qualified Auditor for ISO 13485 and 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