Senior Lead Auditor – In-vitro diagnostic medical devices

il y a 3 jours

Arcueil, France SGS Temps plein
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

For application, please submit 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 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 standard 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 in all levels of an organisation.

  • Senior Lead Auditor – In-vitro diagnostic medical devices

    il y a 3 jours

    Arcueil, France SGS Temps plein

    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...

  • Product Assesor

    Il y a 5 mois

    Arcueil, France SGS Temps plein

    **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. As a **Product...

  • Senior Software Developer

    il y a 2 semaines

    Arcueil, Île-de-France Cora Temps plein

    We are looking for a skilled Senior Software Developer to join our team at {company}.Key Responsibilities:Lead the development team in designing and implementing software solutions.Collaborate with cross-functional teams to identify and prioritize project requirements.Ensure high-quality code delivery and adherence to coding standards.Requirements:5+ years...

  • Inspecteur Itinérant Dispositifs Médicaux

    Il y a 5 mois

    Arcueil, France FR-Amtech Medical Temps plein

    Description de l'entreprise Nous sommes SGS, le leader mondial du testing, de l’inspection et de la certification. Reconnue comme la référence en termes de qualité et d’intégrité, SGS exploite un réseau de plus de 2 650 bureaux et laboratoires à travers le monde et emploie plus de 98 000 collaborateurs travaillant ensemble pour permettre un monde...

  • Senior Software Engineer

    il y a 2 semaines

    Arcueil, Île-de-France Igesa Temps plein

    As a Senior Software Engineer at {company}, you will be responsible for designing, developing, and testing software applications. Your primary focus will be on building scalable and efficient software solutions that meet the needs of our customers.Key Responsibilities:Design and develop software applications using various programming languages and...

  • Global Asme Manager

    Il y a 5 mois

    Arcueil, France SGS Temps plein

    Company Description **SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 98,000 employees, SGS operates a network of over 2,700 offices and laboratories around the world.** **Job Description**: As Global ASME Manager, you act as the...

  • Senior Software Engineer

    il y a 2 semaines

    Arcueil, Île-de-France UCPA Temps plein

    About the Role:As a Senior Software Engineer - Cloud Infrastructure at {company}, you will be responsible for designing, building, and maintaining our cloud infrastructure. This includes developing and deploying scalable and secure cloud-based systems, working closely with cross-functional teams to ensure seamless integration, and collaborating with...

  • Technical Innovation Lead

    il y a 3 semaines

    Arcueil, Île-de-France Aramisauto Temps plein

    Technical Lead for Software DevelopmentAt Aramis Group, our IT department is the heart of the entire company, working with an ecosystem of services that enables collaborative development to make work easier and more efficient.Key Responsibilities:Design, develop, and maintain software applications using modern programming languages and frameworks.Write...

  • Agent-front Desk-lead

    Il y a 5 mois

    Arcueil, France Marriott International, Inc Temps plein

    **Job Number** 24053688 **Job Category** Rooms & Guest Services Operations **Location** Courtyard Paris Arcueil, 6 Avenue President Salvador Allende, Arcueil, Val-de-Marne, France VIEW ON MAP **Schedule** Full-Time **Located Remotely?** N **Relocation?** N **Position Type** Non-Management Le/la chef de brigade servira le client de manière efficace,...

  • Technical Innovation Lead

    il y a 3 semaines

    Arcueil, Île-de-France Aramisauto Temps plein

    Software Engineer PositionAramis Group is seeking a skilled Software Engineer to join our team. As a Software Engineer, you will be responsible for designing, developing, and maintaining software applications using modern programming languages and frameworks.Key Responsibilities:Design and develop software applications with a focus on scalability and...

  • Agent-front Desk-lead

    Il y a 5 mois

    Arcueil, France Marriott International, Inc Temps plein

    **Job Number** 24023220 **Job Category** Rooms & Guest Services Operations **Location** Courtyard Paris Arcueil, 6 Avenue President Salvador Allende, Arcueil, Val-de-Marne, France VIEW ON MAP **Schedule** Full-Time **Located Remotely?** N **Relocation?** N **Position Type** Non-Management Chez Courtyard, notre passion est de répondre aux mieux aux...

  • Inspecteur Itinérant Dispositifs Médicaux

    Il y a 5 mois

    Arcueil, France SGS Temps plein

    Nous sommes SGS, le leader mondial du testing, de l’inspection et de la certification. Reconnue comme la référence en termes de qualité et d’intégrité, SGS exploite un réseau de plus de 2 650 bureaux et laboratoires à travers le monde et emploie plus de 98 000 collaborateurs travaillant ensemble pour permettre un monde meilleur, plus sûr et plus...

  • Senior Software Engineer

    il y a 2 semaines

    Arcueil, Île-de-France Action Temps plein

    We are seeking a talented Senior Software Engineer to join our Platform Development team. As a key member of our engineering team, you will be responsible for designing, developing, and deploying scalable and secure cloud-based systems. Your primary focus will be on building and maintaining our cloud infrastructure, ensuring high availability and...

  • Agent-front Desk-lead

    Il y a 5 mois

    Arcueil, France Marriott International, Inc Temps plein

    **Job Number** 23200537 **Job Category** Rooms & Guest Services Operations **Location** Courtyard Paris Arcueil, 6 Avenue President Salvador Allende, Arcueil, Val-de-Marne, France VIEW ON MAP **Schedule** Full-Time **Located Remotely?** N **Relocation?** N **Position Type** Non-Management *** Assist staff with expediting problem payments (e.g.,...

  • Chargé de Planification

    Il y a 5 mois

    Arcueil, France SGS Temps plein

    **Description de l'entreprise** Nous sommes SGS, le leader mondial du testing, de l’inspection et de la certification. Reconnue comme la référence en termes de qualité et d’intégrité, SGS exploite un réseau de plus de 2 650 bureaux et laboratoires à travers le monde et emploie plus de 97 000 collaborateurs travaillant ensemble pour permettre un...

  • Senior Software Developer with expertise in Java and Python for building scalable applications.

    il y a 2 semaines

    Arcueil, Île-de-France STUDI Temps plein

    About the JobWe are seeking a highly skilled Software Developer to join our team. The ideal candidate will have expertise in Java and Python programming languages and be able to build scalable applications using cloud and containerization technologies.Key ResponsibilitiesDesign and develop high-quality software components using Java and Python programming...

  • Senior Software Engineer

    il y a 3 semaines

    Arcueil, Île-de-France Aramisauto Temps plein

    Aramis Group: Where Technology Meets InnovationWe are a leading technology company in online car buying and selling that has transformed the market using innovative tools like machine learning, data, and algorithms.Our mission is to create high-quality, scalable software by working with optimization in mind.You will work with the most advanced technologies...

  • Chargé de projet en conduite d'opérations F/H

    il y a 3 semaines

    Arcueil, Île-de-France Civils de la Défense Temps plein

    Missions Le titulaire du poste est en charge de la conduite d'opérations d'infrastructure. A ce titre, il se voit confier des missions de maîtrise d'ouvrage dont la contractualisation de marchés de diagnostics et de prestations intellectuelles. Il doit être en mesure de rédiger des programmes d'opération, de lancer des concours d'architecture puis de...

  • First Officer

    Il y a 2 mois

    Arcueil, France La Compagnie Temps plein

    **Compagny description** La Compagnie est la compagnie aérienne régulière française qui réinvente la Classe Affaires en une expérience unique et à taille humaine, entre Paris et New York, Milan et New-York et Nice et New York. A bord, les passagers profitent du confort de 76 sièges-lits qui s’inclinent en lits parfaitement plats, d’un système de...

  • Auxiliaire de Puériculture

    Il y a 5 mois

    Arcueil, France HAYS Temps plein

    Rejoignez une entreprise experte sur son secteur et renforcez les équipes en place. Nous recrutons pour un groupe de crèches privées, des Auxiliaires de puéricultures en CDI à temps-plein à Arcueil dans le Val-de-Marne (gare de Laplace : RER B). Vous travaillez dans un environnement agréable, parfaitement adapté aux tout petits et conçu par une...