Auditor/Project Manager - Medical Division

To strengthen the Medical Division, my client is looking for an Auditor/Project Manager. with expertise in active medical devices. This position entails analyzing technical documentation and conducting inspections. The successful candidate will also contribute to the development of electrical safety and electromagnetic compatibility tests.

Job Description: The selected individual will be responsible for the effective and comprehensive management of assigned projects, including:

• Evaluating technical documentation for electromedical products.
• Conducting inspections at client facilities in accordance with ISO 9001/13485, Directive 93/42/EEC, and Regulation 2017/745.
• Assisting with the preparation of tenders within their area of expertise.
• Compiling reports on inspection activities.
• Overseeing the certification processes for client companies.
• Providing technical and regulatory support to the laboratory coordinator for testing activities.
• Monitoring testing activities related to assigned electromedical devices.

Requirements:

• Bachelor’s degree in Electronic Engineering, Biomedical Engineering, or a related field.
• Familiarity with industry standards and regulations, particularly the IEC 60601 series.
• Required experience with electromedical products.
• Previous laboratory experience is necessary.
• Strong entrepreneurial mindset and organizational skills.
• Excellent analytical abilities.
• Outstanding interpersonal skills.
• Proficiency in English.
• Native Italian speaker or fluent.

Preferred Qualifications:

• Knowledge of ISO 13485.
• Completion of a 40-hour Auditor training course.