Electromedical Product Specialist
4 settimane fa
Luminary Group is seeking a highly skilled Auditor/Project Manager to join our team. As a key member of our Medical Division, you will be responsible for ensuring the effective management of assigned projects, including the analysis of technical documentation and the conduct of inspections.
Key Responsibilities:
- Evaluate technical documentation for electromedical products to ensure compliance with industry standards and regulations.
- Conduct inspections at client facilities to verify adherence to ISO 9001/13485, Directive 93/42/EEC, and Regulation 2017/745.
- Assist with the preparation of tenders within your area of expertise.
- Compile reports on inspection activities to provide valuable insights to stakeholders.
- Oversee the certification processes for client companies to ensure seamless integration.
- Provide technical and regulatory support to the laboratory coordinator for testing activities.
- Monitor testing activities related to assigned electromedical devices to ensure quality and compliance.
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.
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