Medical Devices Auditors / Product Reviewer Rho

Medical Devices Auditors / Product Reviewer
Rho
Lombardia, Rho

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