Sterility Assurance Specialist Sterile Devices

Solothurn  ‐ Vor Ort
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Schlagworte

Beschreibung

Tasks:

  • Create, review, correct and release any documents to cover the company sterilization program (eg Gamma sterilization Program).
  • Correspond with internal and external customers with special requests regarding the company sterilization program.
  • Support and ensure sterility validations (eg dose establishing, dose audits, dose mappings) for all product families are remediated and following the current standards.
  • Train PD, consultant and other personnel in basic sterilization and in sterilization procedures.
  • Review all vendor sterility assurance validation protocols and reports to ensure company and regulatory requirements are met.
  • Create internal validation and re-validation protocol and reports.
  • Other duties/responsibilities as assigned by manager.
  • Requirements:

  • Knowledgeable in applicable Medical Device Directive (MDD), ISO13485, ISO 14971, ISO 9001 and FDA (QSR) regulations.
  • Well versed in grnment regulations and industry guidelines for sterilization (eg EN ISO 11137-x, EN ISO 556-2, EN ISO 11135) and microbiological control of medical devices.
  • At least 5 years' experience in gamma validation, preference with metal and plastic medical devices.
  • Experience in ETO validation is an advantage
  • This position requires a high level of written and oral communication skills and the ability to interact with managers at all levels as well as personnel at the operating unit level.
  • Working knowledge of applicable software, particularly Microsoft Office applications.
  • Excellent organizational skills
  • English needed and German would be an advantage
  • Qualification from collage or higher education
  • Professional experience for at least 5 years
  • Are you interested in this position? Then we are looking forward to receiving your application.

    Start
    keine Angabe
    Dauer
    31/05/2015
    Von
    Harvey Nash IT Recruitment Switzerland
    Eingestellt
    06.03.2015
    Projekt-ID:
    863229
    Vertragsart
    Freiberuflich
    Um sich auf dieses Projekt zu bewerben müssen Sie sich einloggen.
    Registrieren