Qualification Specialist Medical Devices - Granarolo, Italia - Kiwa Cermet Italia S.p.A. Granarolo dell'Emilia,

Kiwa Cermet Italia S.p.A. Granarolo dell'Emilia,

Azienda verificata

Granarolo, Italia

1 settimana fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Job Summary

Are you a specialist in the medical or medical devices sector? Have you ever thought of using your specialism to contribute to the safety and performance of medical devices according to the European Medical Device Regulation? Do you want to further build on your experience in an ambitious international company? Then you might well be Kiwa's new Qualification Specialist.

About the role
In the role of Qualification Specialist, you have to ensure the proper management of the qualification process and related maintenance of experts involved in conformity assessment and internal technical reviews under the EC certification of Medical Devices

After an extensive internal training program, you:

Manage the qualification process (initial, extensions and periodic maintenance) of the personnel who carry out the internal technical reviews and conformity assessments activities;
Support the Manager for issuing authorizations to the qualification of the people involved in conformity assessment activities;
Manage the correct archiving of all documents for qualifications and authorizations;
Interface with accreditation and control bodies (designating authorities, representatives of the European Commission) during periodic audits.

Do you have what it takes?

You want to take a new step in your career and are interested to further develop your knowledge and skills.

You are ready to receive an internal training program to become qualified as Kiwa Qualification Specialist. You get energy from contributing to the quality of Kiwa services. You can work independently as well as in a team and take ownership for your work. You have good communication skills, informing and reporting to stakeholders in a clear and timely manner.

For this position, we'd like you to bring these educational and personal skills:

A PhD., MSc. or BSc. in relevant product or medical area such as biomedical engineering, mechanical engineering, physics, biotechnology, biomaterials, medicine, odontoiatric or relevant other sciences;
A minimum of 4 years experience in the field of healthcare products or related activities. The proven knowledge and experience must include a broad base of knowledge of medical device technologies as well as the design and manufacture of devices;
Adequate knowledge of current EU legislation regulating medical devices, including expected conformity assessment procedures, related harmonized standards, guidelines and common specifications;
Experience as a qualified medical device conformity assessment personnel for a notified or accredited body is an advantage.

What can you expect from us in return?

As a Qualification Specialist at Kiwa, you'll hold a challenging position in a technically oriented, ambitious, expanding international Notified Body organisation.

At Kiwa, we value your professional development and personal wellbeing.

When it comes to our terms and conditions, we offer you a salary tailored to your professional competence and experience, including important benefits:

luncheon vouchers;

- annual welfare vouchers;
- additional health insurance.

Where you'll work

In this role, you will work for Kiwa Cermet Italia, at the company office or remote from home (for 8 days per month).

You will be part of the Medical Devices team:
a friendly, close-knit, professional team made up by over 30 very skilled people. You will work for and report to the Technical Manager of the Medical Devices Division.

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