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)