Medical Devices Auditors

1 settimana fa


Rho, Italia MTIC GROUP A tempo pieno

**MTIC InterCert** is growing steadily and successfully in all areas of Certification, particularly as a **Notified Body** in **Medical Device Certification**.

Technical Experts, Lead Auditors, Auditors and Clinical specialists for Conformity Assessment activities for Medical Devices according to Directive 93/42/EC and soon, for EU Regulation 2017/745 are always welcome to cooperate with our team at our offices in Europe: activities will include both technical documentation assessments and QMS audits, including EN ISO 13485 audits.

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**:
General Requirements:

- 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 pieno

Disponibilità:

- Dal lunedì al venerdì



  • Rho, Italia MTIC Group A tempo pieno

    **About the job** **MTIC InterCert **with its over 50 years of experience and knowledge in the field of testing, inspection, certification and testing has been serving to its customers internationally. MTIC InterCert is growing steadily and successfully in all areas of Certification, particularly as a Notified Body in Medical Device Certification....