IVDR Lead Auditor

19 hours ago


Ellesmere Port, Cheshire, United Kingdom SGS Full time
Auditor Career Advancement Opportunity

We are seeking a highly skilled IVDR Lead Auditor to join our team at SGS. This is an exciting opportunity for experienced professionals looking to advance their careers in auditing.

About the Role

The successful candidate will be responsible for supporting the development of our global medical device auditor network, mentoring junior colleagues, and contributing to the continuous improvement of our processes and tools.

The ideal candidate will have previous auditing experience within an IVD or IVDR notified body, with a minimum of 4 years 'hands-on' professional experience in designing, manufacturing, or testing of IVDs. They should also have knowledge of EU IVDR 2017/746 and standards relevant to in-vitro diagnostic medical devices.

The estimated salary for this role is $130,000 - $170,000 per annum, depending on experience. We offer a remote working environment and opportunities for international travel.

Key Responsibilities
  1. Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors.
  2. Act as a key point of contact for SGS medical device offices, mentor junior colleagues, and help coordinate the expansion of the IVDR auditor network.
  3. Contribute to the continuous improvement of processes and tools used across the SGS network to conduct IVDR conformity assessment.
  4. Complete specific projects about medical device procedures, processes, systems, and documentation as requested by the Medical Devices Manager.


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