Product Evaluator

hace 5 días

Madrid Centro, Madrid, España SGS A tiempo completo

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.

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