Medical Device Auditor

Mô tả Công việc
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.