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Product Assessor
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Job DescriptionTo conduct Sterilisation technical file reviews against European Medical Device Directive and Medical Device Regulation for Class IIa /IIb and/or Class III within the defined timeframeSupport CE marking activities carried out by SGSProvide guidance and assistance in training and qualifying junior staff members.
Develop and create training materials to enhance the skillset of the teamEffectively communicate with internal team members and clients regarding product assessments and related activitiesWork proactively to minimize risks associated with medical device certifications.
QualificationsPlease submit your English CV.Required experience and qualifications are:Four years industrial experience with medical device manufacturing that includes at least two years of experience in the operation of the relevant sterilization processes (ETO, Irradiation, Steam, Aseptic etc.
), clean room controls, shelf life studies, including validation of the considered process for which they wish to be qualifiedUniversity or technical college degree or equivalent qualification including Microbiology modules or relevant studies medicine, pharmacy, engineering or other relevant sciencesMedical device/ procedure packs Sterilisation process knowledge in following methods- (MDS1005/ MDS1011)Non-active, non-implantable devices for disinfection, cleaning and rinsing (MDN1211) Devices manufactured in clean rooms and associated controlled environments (MDT2008)Good communication techniques through electronic mediumsGood English literacy for the preparation and review of reports
