Medical Device Auditor

We are looking for a Medical Device Auditor to join our Medical and Health Service team. In this role, you will play a key part in supporting global medical device manufacturers by assessing and ensuring their Quality Management Systems (QMS) comply with international regulatory requirements and certification standards.

As a Medical Device Auditor, you will conduct audits at manufacturers’ facilities, evaluate compliance with medical device regulations, and work closely with customers throughout the certification process.

This is an excellent opportunity for professionals who want to expand their expertise across a wide range of medical device technologies and contribute to improving the safety and quality of healthcare products worldwide.

Medical Device Technologies Covered:

• Emerging technologies: Software as Medical Device (SaMD)/ Artificial Intelligence (AI)-based medical applications/ Medical device cybersecurity
• Established technologies: Orthopedic devices and implants/ Medical imaging equipment/ Patient monitoring devices/ Tubing systems/ Gloves and other medical consumables

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
• 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 
• Actively promote and embed Equality Diversity and Inclusion (EDI) in all work, and support and comply with all organizational initiatives, policies and procedures on EDI.
• The job holder has to behave at all times in a manner consistent with all applicable local laws, TÜV SÜD Company values and Code of Ethics and to actively promote this to others as well.
• Take reasonable care to ensure your own and others’ health and safety. Advocate and promote the Company’s Health, Safety and Well-being strategy and policies.

• Bachelor’s degree in Engineering, Biomedical Science, Life Sciences, or another relevant scientific discipline, with a diploma or equivalent qualification related to Non-Active Medical Devices. Relevant fields include Biomedical Engineering, Clinical Laboratory Science, Pharmacy/Pharmaceutical Sciences, Mechanical Engineering, Materials Engineering (particularly for implants and medical devices), Chemical Engineering (e.g., biomaterials, coatings, polymers), and Life Sciences such as Biology, Microbiology, or Biotechnology.
• Minimum 4 years of relevant experience in the medical device industry, particularly in Production, Quality Assurance (QA), Testing of Medical Devices, Design and Development Activities, Process Validation, and/or Application of Process Technologies.
• At least 2 years of experience in a Quality Management System (QMS) environment, such as Manufacturing, Quality Control, or Research
• Qualified Auditor for ISO 13485 and experience with MDR / IVDR and/or MDSAP would be a strong advantage.
• Experience in medical device sterilization would be an advantage, particularly in Ethylene Oxide (EO), Moist Heat/Steam, Gamma/E-Beam, Hydrogen Peroxide (H₂O₂), or other sterilization technologies, including relevant sterilization or process validation experience.
• Clear and articulate presentation ability with excellent communication skills.
• High level of customer orientation and the ability to manage challenging audit situations professionally.
• Fluent English communication skills, both written and spoken.
• Willingness and ability to travel within ASEAN, with occasional travel to the USA and Europe.

Others (Benefit):

• Working in an international dynamic and friendly environment
• 15 annual leaves, 15 paid sick leaves, Christmas leave
• 13th-month salary, bonus based on performance and business result
• Social insurance, health insurance, unemployment insurance base on full basic salary (Vietnamese Law)
• Insurance benefits package (Accident insurance 24/7, Health care insurance, Business travel insurance), annual health check
• Free parking 
• Ad-hoc staff engagement events, team-building activities, company trip
• Participate in the company’s training programs, LinkedIn Learning license holder (fee supported by company base on company’s policy)