Medical Devices Lead Auditor & Training Specialist Milano

Medical Devices Lead Auditor & Training Specialist
Milano
Lombardia, Milano

Job DescriptionWe currently have an exciting opportunity at SGS for a Medical Devices Lead Auditor & Training Specialist to join our highly successful Global Medical Device team. In this role you will be reporting directly to the Global Medical Devices Technical Training Manager. Your role will have dual responsibilities as Lead Auditor and Auditor Training Specialist as follow:Main Purpose of RoleAs a Lead Auditor:To develop and deliver, at the locality and/or on-line, Auditor Training materials for the global business scope. To evaluate and approve Trainee Auditors L1 audits. To ensure the auditor qualifications remain in place; support planning and conduct management system audits in accordance with SGS procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standardsBe a key expert of contact and mentor to colleagues and play a key role in the qualification of new auditors. As a Training Specialist/Facilitator:In line with the personnel management procedures, help prepare, deliver and assess training and integration aspects of the qualification process. Key areas of responsibilitiesAs a Lead Auditor: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 MDR/IVDR conformity assessment. Maintain own auditor competencesConduct 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 ManagerAs a Training Specialist/Facilitator:Supporting the Training team to prepare and maintain core training courses pertaining to medical devices. Supporting the Training team to conduct peer reviews and assessmentMaintain up to date knowledge of relevant medical device regulationsSupport and/or deliver external trainings – including administrative supportQualificationsAs a Lead Auditor:EssentialFull knowledge of EUMDR 2017/745Previous auditing experience within an MDR notified body is mandatoryA 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 TechnologyGeneral Expertise including but not limited to Risk Management (ISO 14971), Usability, Biocompatibility, ClinicalStandards and guidance documents relevant to medical devicesMeet the prerequisite per LPMDREG7001 for MDR and/or LPIVDREG7106 for IVDRDemonstrate 2 years working knowledge on MDN/MDA/MDS codes for MDR. Good English written and verbal skills. Experience of working under own initiative and in planning and prioritising workloadsWillingness to travel Internationally as required (60% of time)DesirableKnowledge of EU IVDR 20017/746Appointed Lead auditor by Notified Body under ISO 13485, MDR, IVDR, UKCA within the last 3 years. Demonstrate working knowledge in IVR/IVS codes for IVDR as per LPMDR. IVDR700Meeting Prerequisite per LPMDREG7048 section 3 as Level 1 auditorKnowledge of other EU languageAs a Training Specialist/Facilitator:EssentialProven experience in training and assessmentExperience in creating and maintaining training materialExcellent communication skillsBachelor level education – preferably in engineering/science/research based subjects or modulesIT literacy