Quality Engineer (m/f/x) Sterilization Validation for Implants/Instruments

☞ Smith+Nephew

Ver: 201

Dia de atualização: 29-03-2024

Localização: Aarau Aargau AG

Categoria: Segurança de qualidade / Controle de qualidade Outro

Indústria: Medical Equipment Manufacturing

Posição: Associate

Tipo de empregos: Full-time

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Conteúdo do emprego

Smith+Nephew is a portfolio medical technology business that exists to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 18’000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT.

At our site in Aarau(Kanton Aargau), we are looking for a

Quality-Validation Engineer (m/f/x) Sterilization Validation for Implants/Instruments

Your main tasks
  • Responsible for the sterilization process of medical devices (Gamma and EO sterilization), including the development, validation, and maintenance of routine production with planning of controls and regular assessments of data and processes
  • Implementation of validations at external service providers for Gamma and EO sterilization
  • Preparation of the technical documentation for Gamma and EO sterilization of medical devices for submission to Notified Bodies and authorities
  • Supervision of product transfer projects in the context of sterilization issues
  • Creation of SOPs

Your profile
  • Degree (University of Applied Sciences, technical school) in a STEM subject or equivalent training in microbiology
  • Knowledge of the regulatory requirements for the sterilization of medical devices (Gamma & EO)
  • If possible – not required: Experience in validation of sterilization processes (Gamma & EO)
  • Experience in communicating with Notified Bodies and authorities
  • Experience in evaluating microbiological analyses
  • Independent, committed and goal-oriented way of working
  • Quick comprehension of processes and technical issues
  • Very good written and oral language skills in English and German

We Offer:
  • Excellent development opportunities in a market-leading, internationally successful company
  • The opportunity to play a relevant part in a medical network and to further develop a company with an excellent reputation
  • A team of committed, experienced and team-oriented colleagues
  • Flexible working hours and the option to partly work from home
  • Attractive employment conditions, modern infrastructure and social benefits

Does this sound interesting to you? Then we would like to get to know you by (video) phone call. Please send us your CV (PDF) via our career portal.

Merve Krabbenhöft, Talent Acquisition Specialist, Smith & Nephew

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Data limite: 13-05-2024

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