Join Kiwa as a Product Assessor / Lead Auditor for Medical Devices SoftwareKiwa, a leader in Testing, Inspection, and Certification (TIC), is seeking a skilled Product Assessor / Lead Auditor to join our Medical Division, with a global presence and extensive expertise in medical device certification.Role Description:As a Lead Auditor, you will be responsible for conducting audits on clients and manufacturers of active medical devices/software, ensuring compliance with Medical Device Regulations (MDR), Directive 93/42/EEC, and ISO 13485 standards. After internal training, your duties will include:Managing the entire quality management system audit process for manufacturers and suppliers of active medical devicesPerforming audits for a diverse range of clients, from innovative startups to large international companiesReviewing technical documentation in accordance with MDR and Directive 93/42/EECMaintaining regular contact with clients regarding audit activities and follow-upsCollaborating with colleagues within your area of expertiseTraveling domestically and internationally up to 70% of the timeQualifications:Master's degree in Electronic Engineering, Computer Science, or related fieldAt least four years of professional experience in the medical sector, especially in manufacturing of electromechanical medical devices (software) per Directive 93/42/EEC, including quality, production, design, and testing areasExperience in designing and programming standalone or embedded medical device software is a plusKnowledge of Artificial Intelligence and experience working with AI software is advantageousFamiliarity with ISO 13485, ISO 9001, and ISO 14971 standardsExcellent command of EnglishBenefits:Company car for personal and professional useMeal vouchersPerformance bonuses and annual welfare programsSupplementary health insuranceFlexible working hoursAdditional leave for medical visitsOngoing training programsThis role offers an exciting opportunity to work within a dynamic, international team of over 40 professionals, with frequent travel opportunities across Italy and abroad. Remote work is possible for back-office activities. The position reports to the Technical Division Manager.Join Kiwa and be part of a global organization operating across multiple market segments, including management system certification, product certification, CSR, testing, and metrology. With over 10,000 employees in more than 40 countries, Kiwa is committed to your professional growth and well-being.
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