Auditor/Project Manager - Active Medical Devices Milano

Auditor/Project Manager - Active Medical Devices
Milano
Lombardia, Milano

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.