Medical Devices Lead Auditor

3 weeks ago

loughbeg municipal district of carrigaline ireland TN Ireland Full time

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Medical Devices Lead Auditor & Training Specialist, Loughbeg

Client: SGS

Location: Loughbeg, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference: 76ce4d8de3b4

Job Views: 6

Posted: 08.02.2025

Expiry Date: 25.03.2025

Job Description:

We currently have an exciting opportunity at SGS for a Medical Devices Lead Auditor & Training Specialist to join our highly successful Global Medical Device team.

In this role you will be reporting directly to the Global Medical Devices Technical Training Manager.

Your role will have dual responsibilities as Lead Auditor and Auditor Training Specialist as follows:

Main Purpose of Role

As a Lead Auditor:

  • To develop and deliver, at the locality and/or on-line, Auditor Training materials for the global business scope.
  • To evaluate and approve Trainee Auditors L1 audits.
  • To ensure the auditor qualifications remain in place; support planning and conduct management system audits in accordance with SGS procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
  • Be a key expert of contact and mentor to colleagues and play a key role in the qualification of new auditors.

As a Training Specialist/Facilitator:

  • In line with the personnel management procedures, help prepare, deliver and assess training and integration aspects of the qualification process.

Key areas of responsibilities

As a Lead Auditor:

  • Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors. This will involve witnessing of qualification audits, providing formal and informal feedback on trainee performance, delivering training and coaching.
  • Act as a key point of contact for the SGS medical device offices, a mentor for junior colleagues and help coordinate the expansion of the IVDR auditor network.
  • Contribute to the continuous improvement of the processes and tools used across the SGS network to conduct MDR/IVDR conformity assessment.
  • Maintain own auditor competences.
  • Conduct audits at clients’ sites and remotely, following established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
  • Work alone or lead audit teams as appropriate, enhance client satisfaction and ensure compliance with standards and regulatory requirements.
  • Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
  • Complete specific projects about medical device procedures, processes, systems and documentation as requested by the Medical Devices Manager.

As a Training Specialist/Facilitator:

  • Supporting the Training team to prepare and maintain core training courses pertaining to medical devices.
  • Supporting the Training team to conduct peer reviews and assessment.
  • Maintain up to date knowledge of relevant medical device regulations.

Qualifications

As a Lead Auditor:

  • Full knowledge of EUMDR 2017/745.
  • Previous auditing experience within an MDR notified body is mandatory.
  • 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.
  • General Expertise including but not limited to Risk Management (ISO 14971), Usability, Biocompatibility, Clinical Standards and guidance documents relevant to medical devices.
  • Meet the prerequisite per LPMDREG7001 for MDR and/or LPIVDREG7106 for IVDR.
  • Demonstrate 2 years working knowledge on MDN/MDA/MDS codes for MDR.
  • Good English written and verbal skills.
  • Experience of working under own initiative and in planning and prioritising workloads.
  • Willingness to travel Internationally as required (60% of time).
  • Knowledge of EU IVDR 20017/746.
  • Appointed Lead auditor by Notified Body under ISO 13485, MDR, IVDR, UKCA within the last 3 years.
  • Demonstrate working knowledge in IVR/IVS codes for IVDR as per LPMDR.IVDR700.
  • Meeting Prerequisite per LPMDREG7048 section 3 as Level 1 auditor.
  • Knowledge of other EU language.

As a Training Specialist/Facilitator:

  • Proven experience in training and assessment.
  • Experience in creating and maintaining training material.
  • Bachelor level education – preferably in engineering/science/research based subjects or modules.
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