Electrical Quality & Validation Engineer

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Electronicalengineer/Elektroingenieur oder Elektrotechniker FHElectrical - Quality & Validations Engineer (Medical Device) For my client, part of a global Medical Device Manufacturer, I am currently looking for a specialist in Electrical Quality Engineering, managing Complaint investigations, FMEAs and supports Projects related to Manufacturing, Validation and Process improvement, as well as Audits and Compliance (MDR) Location: Central SwitzerlandDuration: minimum 6 months, with potential extensionDepartments: Quality Management/EngineeringActivities: Technical Complaint Investigations, Validations, Process improvementsElectrincal- Quality & Validations Engineer Main Responsibilities Responsible for Root Cause Analysis and complaint investigations for medical soft- and hardware applicationsManaging tests and technical improvements related to Product Failures and FMEAsWorks closely with R&D and Manufacturing Engineering on Design and Process Validations and Qualification of EquipmentEvaluate, review and approve Validation and Qualification plans and reports and Risk filesResponsible for complete handling of Electrical and mechanical parts returned from the field for complaint investigationsAnalyze and report trends and statistical data from investigations with R&D and company managementResponsible for providing support and communication with external customers to resolve quality issues and other related product concerns The profile Bachelor or Master's Degree in Electrical Engineering or similar education3 years of experience in a similar position in a highly-regulated environment, preferable in Med-Tech industryGood knowledge of the Med-Tech Industry regulations (ISO13485/ FDA 21CFR820 / GMP) or other highly regulated industryExpertise for failure investigations in soft- and hardware applicationsExperience in active device and knowledge of its Standards e.g IEC 60601In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methodsExperience in Project ManagementExperience with CAPA processesExperience in communication with customers and suppliersVery good written and spoken knowledge in English and preferably in German Should you be interested in a hands project in Central Switzerland, in a global Medical Device company? Kindly get in contact with me and send me your updated CV.I am looking forward to hear from you, s.keel(at)realstaffing.comSthree Switzerland is acting as an Employment Business in relation to this vacancy.