Medical Devices Auditors / Product Reviewer Rho

Medical Devices Auditors / Product Reviewer
Rho
Lombardia, Rho

About the job

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 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

- **The search is aimed at both sexes (L. 903/77).

Please read the privacy policy in accordance with Art.

13 of Regulation (EU) 2016/679 on data protection (GDPR)**_

Ability to commute/relocate:

- 20017 Rho, LOM: Reliably commute or planning to relocate before starting work (required)

Work Location: One location