Auditor/Project Manager - Active Medical Devices Bardi

Auditor/Project Manager - Active Medical Devices
Bardi
Emilia Romagna, Bardi

The individual will be responsible for the effective and thorough management of assigned projects, including: Evaluating the documentation of Technical Files for accuracy and completeness. Conducting inspections at client facilities in accordance with ISO 9001, ISO 13485, and Directive 93 / 42 / EEC. Guiding companies through their certification processes. Assisting, as appropriate, in the preparation of proposals and offers. Creating detailed reports on inspection activities. Contributing to the development of the internal Quality System as relevant. Requirements Background from another institution or as a Technical Director (CTF) in pharmaceutical companies that also operate in the medical device sector. Degree in Chemistry, Pharmacy, Biology, or a related field. 3-5 years of experience in the pharmaceutical industry, followed by experience in the medical device sector, or 3-5 years of experience specifically in the medical device sector involving substances. Knowledge of industry standards and regulations, including IEC 60601. Technical expertise in medical devices containing substances. Entrepreneurial mindset and strong organizational skills. Strong analytical abilities. Excellent interpersonal skills. Proficiency in English. Native Italian speaker or fluent in Italian. J-18808-Ljbffr