Sterilization Expert ETO & Gamma

31 May 2024

Vacancy expired!

Hi professionalRole : Sterilization Expert ETO & GammaLocation :Trumbull, CTduration :Long term

Key Accountabilities;• Ensure regulatory compliance of technical file reviews under applicable EU Medical Devices Directives and /or Regulations• Conduct reviews (primarily desk based, but occasionally may be on site) in accordance with established procedures, maintaining a high standard of service delivery.• Maintain personal competence and development in qualified specialist areas on an ongoing basis• Project manage reviews as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards• Work at all times to adhere to KPI’s set as an individual and within a team• To ensure personal competency is maintained to be able to review technical files and technical documentation• Maintenance of MDD/MDR or IVD/IVR Product Assessor status• Ensure that the highest level of service is provided throughout the SGS network offering Medical Devices certification and final customers through efficient service delivery

QualificationsTo be successful in this role, you’ll need a University or technical college degree including microbiological modules or a microbiology degreeIn addition to the above you’ll also need to demonstrate the following;• Extensive professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.• Industrial experience with medical device manufacturing that includes experience in the operation of the relevant sterilization processes including validation of the considered process• Medical device knowledge/codes• Technical File reviews• Knowledge of state-of-the-art standards corresponding to the considered sterilization technology (ETO, Radiation (Gamma and Electron Beam), Steam, Aseptic Process, Hydrogen Peroxide, gas plasma sterilisation• Work experience in a sterilisation facility Thanks & Regards,JeniTechnical Recruiter S2S SOFT LLC

  • ID: #41992610
  • State: Connecticut Trumbull 06611 Trumbull USA
  • City: Trumbull
  • Salary: Depends on Experience
  • Job type: Contract
  • Showed: 2022-05-31
  • Deadline: 2022-07-24
  • Category: Et cetera