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Product Evaluator
hace 2 meses
Job Summary
We are seeking a highly skilled and experienced professional to join our team at SGS as a Product Assessor. As a Product Assessor, you will play a critical role in ensuring the quality and safety of medical devices.
Key Responsibilities
- Conduct thorough technical file reviews of sterilization processes against European Medical Device Directive and Medical Device Regulation for Class IIa / IIb and / or Class III medical devices.
- Support our CE marking activities, ensuring compliance with regulatory requirements.
- Provide guidance and training to junior staff members, enhancing their skills and knowledge in sterilization processes and medical device regulations.
- Develop and create training materials to improve the team's skillset and stay up-to-date with industry developments.
- Effectively communicate with internal team members and clients regarding product assessments and related activities, ensuring seamless collaboration and information exchange.
- Work proactively to minimize risks associated with medical device certifications, ensuring the highest level of quality and safety.
Requirements
- Four years of industrial experience in medical device manufacturing, with at least two years of experience in operating relevant sterilization processes (ETO, Irradiation, Steam, Aseptic, etc.).
- Clean room controls, shelf life studies, and validation of sterilization processes.
- 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 sterilization 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.
What We Offer
As a Product Assessor at SGS, you will have the opportunity to work with a leading global company in the field of testing, inspection, and certification. You will be part of a dynamic team that is passionate about ensuring the quality and safety of medical devices.
