Product Assessor

hace 1 mes

Madrid, Madrid, España SGS A tiempo completo

Company Description

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

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.

Qualifications

Please 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 e.g. medicine, pharmacy, engineering or other relevant sciences
  • Medical 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 mediums
  • Good English literacy for the preparation and review of reports

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