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Senior Lead Auditor – In-vitro diagnostic medical devices

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SGS

1mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Madrid
    Remote
  • Quick Apply

AI generated summary

  • You must have IVD auditing experience, 4 years in design/manufacturing/testing, 2 years in quality assurance, a relevant degree, knowledge of EU IVDR 2017/746, and good English skills.
  • You will mentor trainee auditors, conduct and lead audits, improve processes, manage client relationships, and complete projects on medical device compliance efficiently.

Requirements

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

Responsibilities

  • 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.

FAQs

What is the main focus of this Senior Lead Auditor position?

The main focus of this position is to support the expansion and development of the SGS IVDR certification service, specifically for in-vitro diagnostic medical devices.

What qualifications are required for this role?

Candidates must have previous auditing experience within an IVD or IVDR notified body and a minimum of 4 years of hands-on professional experience in designing, manufacturing, or testing of IVDs, with at least 2 years in quality assurance/management.

Is experience with other medical device regulations a plus?

Yes, knowledge of and/or experience with other regulatory schemes and standards relevant to medical devices, such as IVDD, MDD, MDR, ISO 13485, and MDSAP is desirable, but not essential.

What is the travel requirement for this position?

Candidates must be willing to travel internationally as required for auditing purposes.

Will there be opportunities for mentorship in this role?

Yes, the role involves acting as a mentor for junior colleagues and supporting the qualification of trainee auditors.

What educational background is preferred for candidates?

A university degree or equivalent qualification in relevant sciences such as Chemistry, Biology, Biotechnology, or Engineering disciplines is preferred.

Are there any additional language skills that would be advantageous?

Yes, knowledge of additional European languages would be an advantage.

What are the key accountabilities for this position?

Key accountabilities include supporting auditor qualification, conducting audits, contributing to process improvements, and completing chargeable work within required budgets and timeframes.

Is this position primarily remote or hybrid?

We provide a remote working environment, which may also include hybrid arrangements.

What type of auditing experience is mandatory for this role?

Previous auditing experience specifically within an IVD or IVDR notified body is mandatory.

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SGS

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