LiJob Summary /lipAre you a specialist in the medical or medical devices sector? Have you ever thought of using your expertise to contribute to the safety and performance of medical devices according to the European Medical Device Regulation? Do you want to further develop your experience in an ambitious international company? Then you might be Kiwa’s new Non-active Medical Device Auditor! /pulliAbout the role /lipAs a Lead Auditor, you will perform audits on quality management systems of manufacturers and suppliers of active medical devices, according to the Medical Device Regulations (MDR) and EN-ISO 13485 standard. Our clients range from innovative start-ups to large international companies across various medical devices. /ppbAfter extensive internal training, you will: /b /pliConduct audits independently as a Lead Auditor; /liliManage the audit activities for your clients; /liliMaintain regular contact with clients regarding audit progress and follow-up; /liliCoordinate with colleagues, external experts, and contractors; /liliProvide advice and mentorship to colleagues; /liliTravel approximately 40-70% of your time, both nationally and internationally. /li /ulpOnce experienced with specific device types, you may also review Technical Files and participate in Clinical Evaluation assessments. /pulliDo you have what it takes? /lipYou are eager to advance your career, expand your knowledge, and are prepared for internal training to become a qualified Kiwa Medical Device Lead Auditor. You derive motivation from ensuring product safety and quality. You can work independently and as part of a team, managing your workload efficiently. Strong communication skills are essential for clear, timely reporting to stakeholders. /ppRequired educational and personal skills include: /pliA PhD, MSc, or BSc in biomedical, electrical, mechanical engineering, pharmacy, physics, or information technology; /liliAt least 4 years of experience in healthcare product fields, including 2 years in Quality Management and Regulatory Affairs; /liliExperience with production technologies such as metal, plastic, chemical, biotech, or pharmaceutical processing; /liliExperience with non-active medical devices like orthopaedics, dental implants, bone cements, etc.; /liliKnowledge of harmonized medical device standards, CS, and MDCG documents; /liliExperience with risk management per ISO 14971; /liliFamiliarity with ISO 13485, MDR, and related standards; /liliThird-party auditing experience (considered an advantage); /liliFluent in English; knowledge of German, French, or Spanish is a plus; /liliBased in Italy and authorized to work there; /liliResilient, with the ability to travel frequently across EMEA and beyond. /li /ulpWhat we offer in return includes: /pliA competitive salary based on experience; /liliCompany car, luncheon vouchers, welfare vouchers, health insurance; /liliComprehensive training and career development opportunities. /lipWork location: Kiwa Cermet Italia, Cadriano (BO). You will join a friendly, professional team of over 30 experts, with frequent travel within Italy and internationally. /p #J-18808-Ljbffr