Giacomo Cargnello

Head of Quality Assurance & Regulatory Affairs, C&C Solutions at Varex Imaging

Speaker

Giacomo Cargnello is currently the Global Head of Quality Assurance & Regulatory Affairs for the Business Group Connect&Control Solutions at Varex Imaging Corporation, a world leader in X-Ray imaging components and medical devices such as tubes, generators, high-voltage connectors, and collimators. In this role, he leads a multi-disciplinary team of QA/RA managers and specialists across four sites (The Netherlands, Philippines, China, and USA) and is a key member of the Business Group Management Team.

Throughout his career, Giacomo has held various leadership positions in the Medical Device Industry, working with companies such as Varex, Philips, Baxter, and St. Jude Medical/Abbott. His leadership experience spans overseeing the development and regulatory approval of diverse medical equipment, including implantable pacemakers and defibrillators, hemodialysis equipment, image-guided therapy systems, imaging devices for diagnosis (MR, DXR, CT, PET scans), and medical software products. He has successfully managed teams, driven quality management initiatives, and led projects to ensure compliance with International Regulations and Standards.

Giacomo is a certified Lead Auditor and expert on EU MDR, ISO 13485, ISO 9001, FDA QSReg, Canadian MDR (SOR-98-282), jPMD Act, IEC 60601, ISO 14971, and ISO 62304. He holds a Master’s Degree in Biomedical Engineering (MSc/MEng) and has participated as a speaker at several international QA/RA conferences.