Senior Lead Auditor - In-Vitro Diagnostic Medical Devices

Detalles de la oferta

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: Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors. This will involve witnessing 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 an English CV. Previous auditing experience within an IVD or IVDR notified body is mandatory.A minimum of 4 years 'hands-on' professional experience in 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 2017/746Standards 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 standards 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 at all levels of an organisation.Additional Information

We provide a remote working environment.
Videos To Watch
https://www.youtube.com/watch?v=vso_LZuxki4

#J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Jobleads

Requisitos

24395/ Medico/A Vacaciones - Madrid

Quirónprevención En Quirónprevención, buscamos contar con el mejor talento. Queremos que formes parte de un proyecto que piensa a lo grande, en expansión y q...


Quirónprevención - Madrid

Publicado 23 days ago

Ramp Safety

Descripción de la empresaNuestra unidad de producción se enorgullece de ofrecer un servicio de catering aéreo de lujo de primer nivel, elegante y sofisticado...


Do & Co - Madrid

Publicado 23 days ago

Enfermero/A Empresa Madrid

Solutia Global Health Solutions es la Consultoría de RRHH especializada en los profesionales de las Ciencias de la Vida y la Salud. Nuestra experiencia de má...


Solutiaghs - Madrid

Publicado 25 days ago

24400 Medico/A Vacaciones - Madrid

Quirónprevención En Quirónprevención, buscamos contar con el mejor talento. Queremos que formes parte de un proyecto que piensa a lo grande, en expansión y q...


Quirónprevención - Madrid

Publicado 23 days ago

Built at: 2024-12-21T13:42:49.120Z