Medical Devices Auditors & Product Reviewer Rho

Medical Devices Auditors & Product Reviewer
Rho
Lombardia, Rho

MTIC InterCert of MTIC Group is growing steadily and successfully in all areas of Certification, particularly as a Notified Body in Medical Device Certification. Technical Experts, Lead Auditors & Auditors for Conformity Assessment activities for Medical Devices according to EU Regulation 2017/745 are always welcome to cooperate with our team at our offices in Europe: activities will include both technical documentation assessments and QMS audits, including EN ISO 13485 audits. This opportunity is only available to candidates residing in Italy. We are currently looking for the following additional specific requirements: Auditor: University degree in engineering discipline or chemical science or pharmacy Minimum 4 years of work experience in medical manufacturer of which at least 2 years in quality management or as auditor for other notified bodies. Sound knowledge of MDD 93/42/EEC and Regulation (EU) 2017/745 Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 13485, ISO 14971 Knowledge of English language Lead Auditor training course according to ISO 19011 (40 hours) will be a plus Product Reviewer/Final Reviewer: University degree in engineering discipline or chemical science or pharmacy Sound knowledge of Regulation (EU) 2017/745 Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 14971, ISO 10993 series, EN 62366 Knowledge of English language J-18808-Ljbffr