Medical Devices Auditors

4 giorni 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 languag
Contratto di lavoro: Tempo pieno
Orario:
- Dal lunedì al venerdì

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