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Qms lead auditor manager

Roma
SGS
Auditor
Pubblicato il 21 gennaio
Descrizione

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 98,000employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world. Job Description: Key Accountabilities: - Support with competency approval - To act as mentor for new Auditors when needed - To help with update procedure and forms relevant to medical device QMS auditors to improve the efficiency and productivity - To act as technical managers for all auditors globally and support them with daily queries (technical or operational). - To provide and manage training to Medical device auditors. - To Conduct audits at clients in order to maintain competency - Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Manager. Qualifications: Please submit CV in English. Essentials: A minimum of 4 years ‘hands-on’ professional experience of designing, manufacturing or testing medical devices: - 2 years of the 4 years from working within a formal Quality Management System or working in Quality Management /Regulatory Affairs. - 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. - 3 years previous working experience as Lead Auditor against MDD or MDR within a notified body Knowledge of: - Medical devices (active, non-active or software) and Medical device management systems. - EU MDD 93/42/EEC (UK MDR 2002), EU MDR 2017/745, EU IVDR 2017/746, ISO 13485. - Medical Device Standards. In addition: - Experience of working under own initiative and in planning and prioritizing workloads. - Full driving licence. - Good English written and verbal skills. The following attributes would be desirable, but not essential: - Registered IRCA lead auditor, or equivalent registration under other recognized body. - Experience in delivering training and in engaging and working with people in all levels of an organisation. - Previous management experience - Previous training experience Additional Information This position will be hybrid or fully remote depending on the location.

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