Senior Lead Auditor – In-vitro diagnostic medical devices

at  SGS

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.
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

Please refer the Job description for details