Neolaureato Ing. Biomedico Per Quality Assurance Lazio

Neolaureato Ing. Biomedico Per Quality Assurance
Roma
Lazio, Lazio

Categoria:

Healthcare / PharmaceuticalLuogo di lavoro:

Rovigo e provinciaFor our client, one of the largest global medical technology companies in the world, we are currently looking for a brilliant Biomedic Engineer who want to grow in the Quality Engineering department. Quality Engineering is responsible for supporting MDR transition project, direct responsibilities are on process FMEA development for the company's site, supports also Technical Files updates and associated processes to meet MDR requirements for these manufacturing sites.

Works multi-functionally in the development and or maintenance of pFMEAs. Demonstrates working knowledge of quality engineering policies, principles and standard methodologiesDemonstrates working knowledge of ISO 13485, ISO14971 and MDR 2017/745 requirementsApplies working understanding of regulatory requirements (cGMP, ISO, etc. )

to supportwork with mínimal supervisionPerform Risk Analysis for process Failure Mode and Effect Analysis and participate with different departments and sites for the process evaluation associated with production of the other sitesWrites test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended to support pFMEAWorks with moderate mentorship in own area of knowledge to make technical decisions about product or processes as part of pFMEA and calibration. Support internal and external audits related to Risk Management and CalibrationMain processespFMEAsSituational AnalysisCalibration systemValidation support / MSAProvide different kind of reporting quality data informationParticipate in projects associated with MDR transition and calibration. Requisiti:

Bachelor's degree (Engineering preferable)

Proficient level of English