Beschreibung
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 the Robert-Koch- Institute guidelines, ISO 15883, ISO 17665, and ISO 17664 are required and 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 Synthes sterilization/cleaning program.
Product Development Responsibilities:
Work with PD and Synthes USA to ensure initial product concepts will fit into the Synthes 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.
At least 5 years of experience with reprocessing (eg hospital, CSSD, etc)
Open to understand reprocessing in different countries
Knowledgeable 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 (ie 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
English/German Team Player