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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
  • Hamburg
    Remote
  • Quick Apply

AI generated summary

  • You must have IVD auditing experience, 4 years in design/testing, 2 years in quality assurance, a relevant degree, and knowledge of EU IVDR. Willingness to travel and good English skills are essential.
  • You will mentor trainee auditors, conduct and lead audits, enhance processes, ensure compliance, manage budgets, and execute specific projects related to medical device procedures and documentation.

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
  • 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.

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 primary focus of the Senior Lead Auditor role at SGS?

The primary focus of the Senior Lead Auditor role is to support the expansion and development of the SGS IVDR certification service, specializing in the EU In-vitro diagnostic medical device regulation (IVDR).

What qualifications are required for this position?

Candidates must have previous auditing experience within an IVD or IVDR notified body, a minimum of 4 years of professional experience in the design, manufacturing, or testing of IVDs, and a university degree or equivalent qualification in relevant sciences.

Is experience in quality assurance necessary for this role?

Yes, at least 2 years of the required experience should be in quality assurance/quality management, acquired while working under a structured quality management system.

What type of knowledge should candidates possess?

Candidates should have knowledge of EU IVDR 2017/746 and standards and guidance documents relevant to in-vitro diagnostic medical devices.

Will travel be required in this position?

Yes, candidates must be willing to travel internationally as required.

Are there opportunities for mentoring and training in this role?

Yes, the Senior Lead Auditor will act as a key point of contact and mentor for junior colleagues and will be involved in the qualification and training of trainee auditors.

Is proficiency in additional European languages advantageous?

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

Is remote work supported in this position?

Yes, remote work is provided within a hybrid work environment.

Are there any desirable attributes for candidates that are not mandatory?

Yes, desirable attributes include knowledge of other regulatory schemes relevant to medical devices, experience with medical devices other than IVDs, registration as an IRCA lead auditor, and experience in delivering training.

What is the role of the Senior Lead Auditor regarding client audits?

The Senior Lead Auditor will conduct audits at clients’ sites and remotely while ensuring compliance with standards and regulatory requirements and maintaining effective customer relationships.

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SGS

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