Description
Sterility Assurance ExpertDuration: to
Location: Central Switzerland
Responsibilities:
- Responsible for managing the EU reprocessing cleaning program. Ensures compliance to the applicable Medical Device Directive (MDD), ISO 13485 and FDA (QSR) regulations as they apply to sterilization and reprocessing cleaning.
- Knowledge of prevent infection guidelines, ISO 15883, ISO 17665, and ISO 17664 are required & knowledge of AAMI standards/reports a plus.
- Provides SA oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness throughout the European manufacturing system. This should be accomplished by working closely with Product Development (PD).
- Correspond with customers with special requests regarding the sterilization/cleaning program.
PD Responsibilities:
- Work with PD and USA to ensure initial product concepts will fit into the Sterility Assurance (SA) system.
- Work with PD to ensure timely and complete adoptions and validations of all new products with regard to sterilization and cleaning.
- Train PD personnel in basic sterilization and in sterilization procedures if applicable
- Others responsibilities as given by Sterility Assurance EU
Compliance Responsibilities:
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Requirements:
- At least 5 years of experience with reprocessing (e.g. hospital, CSSD, etc)
- Deep knowledge of reprocessing in different countries
- Broad knowledge in applicable Medical Device Directive (MDD), ISO13485, ISO 14971, ISO 9001 and FDA (QSR) regulations.
- Well versed in government regulations and industry guidelines for sterilization (i.e. ISO/EN/AAMI standards: Robert-Koch-Institute Guidelines, ISO 15883, ISO 17665, ISO 17664)
- This position requires a high level of written and oral communication skills
- Working knowledge of applicable software, particularly Microsoft Office applications.
- Excellent organizational skills and multi-tasking abilities.
- Vocational qualification plus at least 5 years practical experience and supplementary on-going professional training or
- Qualification from college or higher education plus 3 years practical experience
- Languages: German &English fluent.
- Strong language skills and well organized
If you are interesting to get more information regarding this or other positions in Switzerland, please do not hesitate to get in contact with me. .
I am looking Forward to hear from you.
Greetings from Zürich