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QA/quality Engineer
Il y a 2 mois
QA Engineer We are currently recruiting for a QA Engineer at our Dardilly, France.
The QA Engineer is needed to manage the subcontracting site of GANA and acts as the representative of the legal manufacturer.
The ideal candidate must have expertise in lyophilisation process and 4 years’ experience in the medical device, pharmaceutical or biotechnology industries and/or a physical chemistry quality control department.
Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
Driving the advancement of product quality and customer satisfaction, investing in innovation and people.
Activities related to Quality Management system
Manage the subcontracting contract with GANA
Perform audit of the contract manufacturing site, log audit NC in the Corporate system and ensure follow up of the CAPA plan in collaboration with Gana
Participate in the handling of customer complaints and Materi Vigilance cases in collaboration with the Quality and Corporate Vigilance Sinclair departments and with Gana for investigations
4/5 years' higher education in a scientific and/or quality control field.
~4 years’ experience in the medical device, pharmaceutical or biotechnology industries and/or a physical chemistry quality control department.
~ Fluent English (written and spoken)
~ Good command of IT tools (Word, Excel)
~ Knowledge of the Medical Device Regulation 2017/745
Knowledge of Medical Devices regulations (MDR 2017/745)
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