Senior Medical Device Auditor & Lead Auditor (EU MDR)

ph3Overview /h3 pMTIC InterCert of MTIC Group is steadily and solidly growing in all areas of Certification, particularly as a Notified Body (CE 0068) for Medical Device Certification. Due to staff expansion and the opening of a new office in Emilia-Romagna, we are looking for Technical Experts, Lead Auditors, and Auditors for Medical Device Conformity Assessment activities in accordance with Regulation (EU) 2017/745. Activities will include both technical documentation assessments and Quality Management System (QMS) audits, including audits according to EN ISO 13485. This opportunity is exclusively available to candidates residing in Italy. /p pWork location: Rho / Emilia-Romagna /p h3Roles /h3 pProduct Reviewer / Final Reviewer /p ul liUniversity degree in engineering, chemical sciences, or pharmacy /li liMinimum 4 years of work experience with a medical device manufacturer, of which at least 2 years as a product reviewer for Notified Bodies /li liSound knowledge of Regulation (EU) 2017/745 and Directive 93/42/EEC (MDD) /li liSound knowledge of the main horizontal harmonized standards including, but not limited to, ISO 14971, ISO 10993 series, EN 62366 /li liKnowledge of the English language /li liKnowledge of the following MDR codes is preferred: MDA 0201, 0202, 0303, 0306, 0307, 0311, 0312, MDN 1102, 1201, 1202, 1203 /li /ul h3Auditor /h3 ul liUniversity degree in engineering, chemical sciences, or pharmacy /li liMinimum 4 years of work experience with a medical device manufacturer /li liSound knowledge of Regulation (EU) 2017/745 and Directive 93/42/EEC (MDD) /li liSound knowledge of the main horizontal harmonized standards including, but not limited to, ISO 13485, ISO 14971 /li liKnowledge of the English language /li liLead Auditor training course according to ISO 19011 (40 hours) will be considered an advantage /li /ul /p #J-18808-Ljbffr