Senior Lead Auditor – In-vitro diagnostic medical devices

Company Description

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

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.

Key Accountabilities:

1. 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.
2. 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.
3. Contribute to the continuous improvement of the processes and tools used across the SGS network to conduct IVDR conformity assessment.
4. Conduct audits at clients’ sites and remotely, following established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
5. Work alone or lead audit teams as appropriate, enhance client satisfaction and ensure compliance with standards and regulatory requirements.
6. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
7. Complete specific projects about medical device procedures, processes, systems and documentation as requested by the Medical Devices Manager.

Qualifications

1. Previous auditing experience within an IVD or IVDR notified body is mandatory.
2. 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.
3. 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:

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

In addition:

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

Desirable Attributes:

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

We provide a remote working environment.