Senior Lead Auditor – In-Vitro Diagnostic Medical Devices

1 settimana fa

Bardi, Italia Buscojobs A tempo pieno

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 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: 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.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 another 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.

#J-18808-Ljbffr

  • Senior Lead Auditor – In-Vitro Diagnostic Medical Devices

    4 settimane fa

    Bardi, Italia Sgs A tempo pieno

    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...

  • Senior Lead Auditor

    3 settimane fa

    Bardi, Italia Sgs A tempo pieno

    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...

  • Senior Lead Auditor

    2 settimane fa

    Bardi, Italia Sgs A tempo pieno

    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...

  • Senior Lead Auditor

    3 settimane fa

    Bardi, Italia Sgs A tempo pieno

    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...

  • Senior Lead Auditor

    2 giorni fa

    Bardi, Italia Sgs A tempo pieno

    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...

  • Auditor Dispositivi Diagnostici In Vitro

    1 settimana fa

    Bardi, Italia Buscojobs A tempo pieno

    Requisiti specifici Ha una laurea preferibilmente magistrale in discipline scientifiche (biologia, chimica, farmacia, chimica-tecnologie farmaceutiche, biotecnologie) e ha maturato un'esperienza professionale di almeno 3 anni nell'industria di produzione dispositivi diagnostici in vitro direttiva 98 / 79 / EEC e / o Regolamento (EU) 746 / 2017,...

  • Global Regulatory Expert for Medical Devices

    4 giorni fa

    Bardi, Emilia-Romagna, Italia Fresenius Medical Care A tempo pieno

    About Fresenius Medical CareFresenius Medical Care is a global leader in dialysis products and services, dedicated to improving the quality of life for patients worldwide.We operate around the clock at our manufacturing plant in Palazzo Pignano, with over 550 employees working together to produce high-quality bloodlines.As part of our IC Value Stream (VS)...

  • Tecnico Commerciale Medical Devices

    5 mesi fa

    Bardi, Italia Hunters Group A tempo pieno

    884persone hannogià visualizzato questa offerta Dettagli opportunità Settore: Funzione: Tipo di Contratto: Codice opportunità: Descrizione Per nostro cliente, azienda specializzata in analisi in ambito ambientale, farmaceutico, alimentare, sicurezza, stiamo ricercando una figura di Technical Sales – Medical Devices.Principali responsabilità · Gestione...

  • Tecnico Commerciale Medical Devices

    2 mesi fa

    Bardi, Italia Hunters Group A tempo pieno

    Per nostro cliente, azienda specializzata in analisi in ambito ambientale, farmaceutico, alimentare e sicurezza, stiamo ricercando una figura di Technical Sales – Medical Devices.Gestione delle vendite di servizi analitici per dispositivi medici, compresa consulenza e prove di laboratorio; Incremento del portafoglio clienti, focalizzandosi...

  • Auditor/Project Manager

    1 settimana fa

    Bardi, Italia Buscojobs A tempo pieno

    The individual will be responsible for the effective and thorough management of assigned projects, including:Evaluating the documentation of Technical Files for accuracy and completeness.Conducting inspections at client facilities in accordance with ISO 9001, ISO 13485, and Directive 93 / 42 / EEC.Guiding companies through their certification...

  • Senior Quality Specialist

    2 settimane fa

    Bardi, Italia Buscojobs A tempo pieno

    Il nostro cliente è una start up innovativa operante nel settore dei dispositivi medici con applicazione in ambito chirurgico.Realtà fondata da personalità di spicco nel mondo della ricerca scientifica in ambito medico-chirurgico, da qualche anno ha intrapreso un percorso di strutturazione e crescita.Per sede in provincia di Monza (MB), selezioniamo una...

  • Tecnico Commerciale Medical Devices

    3 mesi fa

    Bardi, Italia Hunters Group A tempo pieno

    Per nostro cliente, azienda specializzata in analisi in ambito ambientale, farmaceutico, alimentare e sicurezza, stiamo ricercando una figura di Technical Sales – Medical Devices.Principali responsabilitàGestione delle vendite di servizi analitici per dispositivi medici, compresa consulenza e prove di laboratorio;Incremento del portafoglio clienti,...

  • Senior Quality Specialist

    2 settimane fa

    Bardi, Italia Buscojobs A tempo pieno

    Il nostro cliente è una start up innovativa operante nel settore dei dispositivi medici con applicazione in ambito chirurgico. Realtà fondata da personalità di spicco nel mondo della ricerca scientifica in ambito medico-chirurgico, da qualche anno ha intrapreso un percorso di strutturazione e crescita. Per sede in provincia di Monza (MB), selezioniamo...

  • Tecnico Commerciale Medical Devices

    1 mese fa

    Bardi, Italia Technical Hunters Srl A tempo pieno

    Per nostro cliente, azienda specializzata in analisi in ambito ambientale, farmaceutico, alimentare, sicurezza, stiamo ricercando una figura di Technical Sales - Medical Devices. Principali responsabilità Luogo di lavoro: Pavia Gestione delle vendite di servizi analitici per dispositivi medici, compresa consulenza e prove di laboratorio; Incremento del...

  • Tecnico Commerciale Medical Devices

    1 mese fa

    Bardi, Italia Technical Hunters Srl A tempo pieno

    Per nostro cliente, azienda specializzata in analisi in ambito ambientale, farmaceutico, alimentare, sicurezza, stiamo ricercando una figura di Technical Sales - Medical Devices.Principali responsabilità Luogo di lavoro: Pavia Gestione delle vendite di servizi analitici per dispositivi medici, compresa consulenza e prove di laboratorio; Incremento del...

  • Ivdr Product Assessor

    3 settimane fa

    Bardi, Italia Buscojobs A tempo pieno

    Job Description As an IVDR Product Assessor, you will use your skills as an expert in clinical diagnostic technologies to ensure that patients across Europe have access to safe and effective diagnostic tests.Join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition to the new...

  • Project Manager/Auditor

    3 settimane fa

    Bardi, Italia Buscojobs A tempo pieno

    Luminary Group is seeking a meticulous and detail-oriented Project Manager / Auditor to join a well-established Notified Body company based in Italy.In this role, you will play a key part in delivering high-quality audit services, ensuring compliance with applicable standards and regulations, and making meaningful contributions to the continuous improvement...

  • Lead Auditor Qhse

    2 settimane fa

    Bardi, Italia Buscojobs A tempo pieno

    Siamo alla ricerca di collaboratori che abbiamo esperienza e competenza comeRequisiti richiesti:Esperienza pregressa come Lead Auditor in almeno uno dei seguenti settori: IAF 13 - Farmaceutico, IAF 12 - Chimico, IAF 25-26-27 - Utilities, IAF 04 - Settore Tessile, IAF 06 - Settore LegnoTipo di rapporto di lavoro:Collaborazione a partita IVAVengono...

  • Production Manager Medical Devices

    1 mese fa

    Bardi, Emilia-Romagna, Italia Michael Page A tempo pieno

    Job Title: Operations Manager - Medical DevicesJob Description:We are seeking an experienced Operations Manager to join our client close to Bergamo, Italy. The Operations Manager will play a crucial role in overseeing customer management, operational efficiency, quality assurance, engineering, health and safety, security, and environmental compliance at the...

  • Senior Quality Assurance Specialist Medical Devices

    1 mese fa

    Bardi, Emilia-Romagna, Italia Adecco Italia A tempo pieno

    Adecco LifeScience, a specialized division of The Adecco Group, is seeking a Senior Quality Assurance Specialist to support a company producing medical devices. Key responsibilities include:Key Responsibilities:Coordinating and guiding quality control techniciansDeveloping quality control processes aligned with customer and stakeholder requirementsOverseeing...