Medical Devices Auditors
1 settimana fa
Rho Lombardy, 25, Italia
MTIC Group
Tempo pieno
Gratuito con email o Google
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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.
- Sound knowledge of Regulation (EU) 2017/745 and MDD 93/42/EEC
- 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
- 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 Regulation (EU) 2017/745 and MDD 93/42/EEC
- Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 14971, ISO 10993series, EN 62366
- Knowledge of English language
requirements:
Auditor:
- University degree in engineering discipline or chemical science or pharmacy
- Minimum 4 years of Work experience in medical manufacturer.
- Sound knowledge of Regulation (EU) 2017/745 and MDD 93/42/EEC
- 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
- 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 Regulation (EU) 2017/745 and MDD 93/42/EEC
- Sound knowledge of the main horizontal harmonized standards including, but not limited to ISO 14971, ISO 10993series, EN 62366
- Knowledge of English language