Conformity Assessment Specialist

1 tydzień temu


Warszawa, Mazovia, Polska TN Poland Pełny etat

We are seeking a highly skilled Medical Devices Lead Auditor & Training Specialist to join our Global Medical Device team at TN Poland.

The successful candidate will report directly to the Global Medical Devices Technical Training Manager and work closely with colleagues across the globe. In this role, you will have dual responsibilities as a Lead Auditor and Training Specialist/Facilitator.

As a Lead Auditor, your key responsibilities will include developing and delivering training materials, evaluating and approving trainee auditors' L1 audits, ensuring auditor qualifications remain in place, planning and conducting management system audits in accordance with SGS procedures, and maintaining own auditor competences.

You will also be responsible for conducting audits at clients' sites and remotely, following established procedures, and completing all chargeable work within required budget and timeframes to ensure customer satisfaction and efficiency of the business.

In your role as a Training Specialist/Facilitator, you will support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors, providing formal and informal feedback on trainee performance, delivering training and coaching, helping prepare, deliver, and assess training and integration aspects of the qualification process, and supporting the Training team to prepare and maintain core training courses pertaining to medical devices.

To be successful in this role, you will need to have full knowledge of EUMDR 2017/745 and previous auditing experience within an MDR notified body. You should also have a university degree or equivalent qualification in relevant sciences such as Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science, Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology.

Additionally, you must have excellent written and verbal skills in English, experience of working under own initiative and in planning and prioritising workloads, and willingness to travel internationally as required (60% of time).

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