Senior Lead Auditor – In-Vitro Diagnostic Medical Devices
hace 1 semana
Company DescriptionWe 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 DescriptionWe 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.QualificationsFor 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 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.Desirable Attributes: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 InformationWe provide a remote working environment.SummaryType: Full-timeFunction: Information TechnologyExperience level: Mid-Senior LevelIndustry: Information Services
#J-18808-Ljbffr
-
Medical Devices Auditor
hace 1 mes
España BSI Companies A tiempo completoMedical Devices Auditor - QMSApplyLocation: Spain - field-based, 70%-75% of travel required within EMEAWe’re looking for talented people to join our medical device auditor team. The role involves travelling to various locations to assess quality management systems, supporting patient safety and regulatory compliance. Our audits encompass standards such as...
-
Lead Auditor Medical Devices
hace 1 mes
España Michael Page ES A tiempo completoAs a member of our Medical Device team, you will manage a small team of globally based Product Assessors and dive deep into the exciting world of Active Medical Devices.Responsibilities:Conduct thorough technical documentation reviews and ensure compliance with EU regulations and standards.Collaborate with cross-functional teams to increase efficiency and...
-
Technical Lead
hace 1 mes
España Inbrain Neuroelectronics A tiempo completoTechnical Lead (with Medical Devices Experience)Permanent employee, Full-time · BarcelonaYour missionThe System Architect is responsible for designing and engineering a complex Implantable Neuro-stimulation System and its peripheral equipment. This active medical device will be released in both the EU (requiring CE mark according to the MDR) and the USA...
-
Especialista de Aplicaciones en Ngs
hace 2 semanas
España Palex Medical A tiempo completo**Descripción**: En Palex Medical queremos incorporar a un/a **Especialista de Aplicaciones** **Senior** en nuestra **División de Diagnóstico in Vitro, **con residencia preferentemente en Madrid y **experiência demostrada en el campo de NGS **(preparación librerias, secuenciación y anàlisis de datos). La persona se responsabilizará de realizar las...
-
IVDR Product Assessor
hace 3 semanas
España SGS Société Générale de Surveillance SA. A tiempo completoWe 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.Our Innovation Factory promotes and develops...
-
IVDR Product Assessor
hace 1 mes
España SGS A tiempo completoCompany 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. Our Innovation Factory...
-
IVDR Product Assessor
hace 3 semanas
España SGS A tiempo completoCompany 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. Our Innovation Factory...
-
KAM IBERIA Medical Devices/Cosmética
hace 1 mes
España PMFarma A tiempo completoDesde la división de LifeSciences de LHH Recruitment Solutions estamos seleccionando el perfil de Sales Manager Iberia con experiencia en Medical Devices, residencia en Barcelona.Buscamos perfiles que quieran embarcarse en un proyecto retador en multinacional especializada en el campo de ensayos para cosméticos y dispositivos médicos.¿Buscas una...
-
Regulatory Affairs
hace 2 semanas
España Antal International Network A tiempo completoA growing organization is looking for an experienced Regulatory Affairs Professional to join its expanding Medical Device Unit. This role presents a unique opportunity to work on innovative projects within a dynamic international environment. Ideal candidates will have a passion for medical device regulations and a desire to take on new challenges.Key...
-
Regional Sales Manager
hace 3 semanas
España MESI Medical A tiempo completoWe are a rapidly growing, globally present organization at the forefront of medical innovation with our focus on developing a digital medical-grade tablet that will revolutionize the field of diagnostic testing. We are committed to excellence in healthcare and improving the accuracy and accessibility of diagnostics. Our diagnostic equipment is present in...
-
Senior Product Assessor
hace 1 mes
España SGS Société Générale de Surveillance SA. A tiempo completoSenior Product Assessor - Active DevicesWe 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...
-
Senior Backend PHP
hace 1 mes
España Fagron GmbH & CO. KG A tiempo completoOver de functieWhat profile do we need?To face our growth and product scalability, we need to expand the team with a PHP backend developer (software architect) (Symfony) in our offices in Terrassa (Barcelona).We are looking for a person who is responsible in their work, accustomed to solving problems, with initiative, desire to contribute and face new...
-
Delegado/a comercial Medical Devices Vascular
hace 3 semanas
España LHH A tiempo completoDesde la División de Medical Devices & Healthcare de LHH estamos trabajando con una importante empresa especializada en el sector Medical Devices en la búsqueda de un / a Delegado / a Comercial Junior para Andalucía.RequisitosGrado en Ciencias de la Salud o experiencia demostrable de al menos 1 año en el sector.Inglés C1.Experiencia en puestos similares...
-
Senior Product Assessor
hace 1 mes
España SGS A tiempo completoCompany 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 Are you...
-
Associate Director, Digital
hace 1 semana
España AstraZeneca A tiempo completoAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying...
-
Senior Auditor
hace 4 semanas
España Inspect-China A tiempo completoSenior Auditor(Working Location: Xia’men) Job Description: Perform Factory audits or social audit (including quality management, produce ability, social responsibilities, environment management, C-TPAT, RoHS audit) as clients required including, but not limited to assisting in the development of audit plans; pre-audit preparation. Use established...
-
Auditor IT Senior Barcelona Modelo Híbrido
hace 4 semanas
España Page Personnel España A tiempo completoRevisión de Sistemas de Información en el marco de la auditoría financiera en clientes multinacionales y nacionales de diversos sectores: - Diagnostico de nível de control, seguridad y protección de los activos conforme estándares internacionales: COBIT, ISO 27001, ISO 22301, ITIL - Controles Generales de TI (ITGC): Gobierno de TI, desarrollo,...
-
Associate Director, Digital
hace 2 semanas
España AstraZeneca A tiempo completoAssociate Director, Digital & Devices Safety ScientistAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At...
-
Product Manager-medical Devices
hace 2 semanas
España D&M asesores consultores A tiempo completo**Product Manager-Medical Devices (Barcelona-Tarragona)**: **Empresa especializada en el sector medical devices en plena fase de expansión** Buscamos un responsable de producto con amplia experiência en el sector sanitario (hospitalario, residencial), conocimiento de producto y conocimiento de fabricantes nacionales e internacionales de “_medical...
-
Comercial Junior
hace 4 semanas
España THE WISE SEEKER S.L A tiempo completoEn The Wise Seeker buscamos para importante empresa, concretamente para el sector Health de la Compañía, un/a Comercial - Medical Devices con experiência deseable en sector de la salud. Fidelizar y mantener la cartera de clientes Promocionar el porfolio completo de la compañía, manteniendo y creando nuevas oportunidades Prospectar y establecer acuerdos...
