Senior Lead Auditor – In-vitro diagnostic medical devices

1 miesiąc temu

Warsaw, Polska SGS Pełny etat
Job Description

We currently have an exciting opportunity at SGS for an experienced lead auditor specialising in the EU In vitro diagnostic medical device regulation (IVDR). This role will support the expansion and development of the SGS IVDR certification service across our global network. As a senior expert you will be a key point of contact and mentor to colleagues and play a key role in the qualification of new auditors.

For this senior role, we seek candidates with previous experience as lead auditor within an IVDR notified body.

Key Accountabilities:

  • 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 IVDR conformity assessment.
  • 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.

Qualifications

For application, please submit English CV.

  • Previous auditing experience within an IVD or IVDR notified body is mandatory.
  • A minimum of 4 years ‘hands-on’ professional experience of designing, manufacturing or testing of IVDs.
    • At least 2 years of this experience should be in the field of quality assurance / quality management – this should be experience gained while working under a structured quality management system, in a role with responsibility for quality assurance/management.
  • 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.

Knowledge of:

  • EU IVDR 2017/746
  • Standards and guidance documents relevant to in-vitro diagnostic medical devices

In addition:

  • Experience of working under own initiative and in planning and prioritising workloads.  
  • Willingness to travel Internationally as required
  • Good English written and verbal skills

The following attributes would be desirable, but not essential:

  • Knowledge of and/or experience with other regulatory schemes and standard relevant to medical devices, such as IVDD, MDD, MDR, ISO 13485, MDSAP.
  • Work experience with medical devices other than IVDs.
  • Knowledge of additional European languages would be an advantage
  • Registered IRCA lead auditor, or equivalent registration under other recognised body.
  • Experience in delivering training and in engaging and working with people in all levels of an organisation.


Additional Information

We provide remote working environment.

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