Medical Devices Auditors / Product Reviewer

MTIC InterCert of MTIC Group is growing steadily and successfully in all areas of Certification, particularly as a Notified Body (CE 0068) in Medical Device Certification.

Technical Experts, Lead Auditors & Auditors for Conformity Assessment activities for Medical Devices according to EU Regulation 2017/745 are always welcome to cooperate with our team at our offices in Rho, Milan, Italy: activities will include both technical documentation assessments and QMS audits, including EN ISO 13485 audits.

**This opportunity is only available to candidates residing in Italy.**

We are currently looking for the following additional specific requirements:

Auditor:

- University degree in engineering discipline or chemical science or pharmacy




- Minimum 4 years of Work experience in medical manufacturer of which at least 2 years in quality management or as auditor for other notified bodies.
- Sound knowledge of MDD 93/42/EEC and Regulation (EU) 2017/745
- Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 13485, ISO 14971
- Knowledge of English language
- Lead Auditor training course according to ISO 19011 (40 hours) will be a plus

Product Reviewer/Final reviewer:

- University degree in engineering discipline or chemical science or pharmacy
- Sound knowledge of Regulation (EU) 2017/745
- Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 14971, ISO 10993series, EN 62366
- Knowledge of English language

Contratto di lavoro: Tempo completo

Domande di preselezione:

- How many years of work experience do you have at Notified Bodies?
- Are you legally authorized to work in Italy?
- Will you now or in the future require sponsorship for employment visa status?




- Have you completed Lead Auditor training course according to ISO 19011 (40 hours)
- How many years of work experience do you have with ISO 13485?
- How many years of work experience do you have with Medical Device Regulation (MDR)?

Istruzione:

- Laurea triennale (Obbligatorio)

Esperienza:

- Auditor/Lead Auditor: 4 anni (Obbligatorio)
- Product Reviewer: 4 anni (Obbligatorio)

Lingua:

- Italiano (Obbligatorio)
- Inglese (Preferenziale)

Sede di lavoro: Di persona