Sterility Assurance Specialist non-Sterile Devices

Responsibilities:
. This position is responsible for the European Sterility Assurance activities. This position ensures compliance to the applicable Medical Device Directive (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations as they apply to sterilization. Additionally to other applicable Cleaning and Sterilization ISO and EN standards (esp. EN ISO EN ISO 15883, EN ISO 17665, EN ISO 17664), AAMI standards/reports (eg AAMI TIR 12) and other guidance documents as required.
. This position provides Sterility Assurance 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 other Sterility Assurance Team Members in US and EU.

Detailed description:
. Create, review, correct and release any documents to cover the Synthes reprocessing program (eg Cleaning Program, Steam Sterilization Program).
. Support and ensure sterility validations (eg cleaning validation, steam sterilization validation) are remediated and following the current standards.
. Train PD, consultant and other personnel in basic cleaning, disinfection and sterilization procedures.
. Review external validation protocols and reports to ensure Synthes and regulatory requirements are met.
. Create internal validation protocols and reports.
. Ensure that all validations are in compliance with the current clinical reprocessing information given to the customers
. Other duties/responsibilities as assigned by manager.

Skills:
. 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 clinical reprocessing (eg EN ISO EN ISO 15883, EN ISO 17665, EN ISO 17664, RKI guideline, AAMI TIR 12).
. At least 5 years experience in clinical reprocessing (cleaning, disinfection and sterilization).
. Well known with critical design features for clinical reprocessing
. Well known with identification of design features in a drawing
. 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.
. Language: English needed and German would be an advantage

Education and professional experience:
Qualification from collage or higher education
Professional experience for at least 5 years