(D03) | Product Assessor - Sterilisation

Job Description- To 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 timeframe.- Support CE marking activities carried out by SGS.- Provide guidance and assistance in training and qualifying junior staff members.- Develop and create training materials to enhance the skillset of the team.- Effectively communicate with internal team members and clients regarding product assessments and related activities.- Work 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 qualified.University or technical college degree or equivalent qualification including Microbiology modules or relevant studies in medicine, pharmacy, engineering, or other relevant sciences.Medical device / procedure packs Sterilisation process knowledge in the 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 mediums.Good English literacy for the preparation and review of reports.
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