Sterility Assurance Specialist, German, MDD, ISO13485, FDA

The Sterilization Support Specialist role is critical to all documentation and procedures relating to the sterilization process meet exacting standards that the company demand. We are currently seeking a European Sterilization Support Specialist Matter to join the Global Sterilization Task Group.

The candidate will responsible for reviewing sterilization process procedures and then where any opportunities for improvement are identified, writing new procedures that will allow the implementation of those improvements.

The successful candidate will have:
*Knowledgeable in applicable Medical Device Directive (MDD), ISO13485, GDP and FDA (QSR) regulations
*Well versed in government regulations and industry guidelines for sterilization (ie ISO/EN/AAMI standards) and microbiological control of medical devices as ISO 11137-1, ISO 11137-2, ISO 11137-3, EN556 and AAMI TIR33, ISO 11737-1, ISO 11737-2
*Working knowledge of applicable software, particularly Microsoft Office applications
*Knowledge of writing procedures, validation plan and report templates
*Experience of gamma sterilization
*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
*Excellent organizational skills
*Excellent multi-tasking abilities
*Work as part of a team
*A strong focus on a high level of service delivery

This is a key position within the European operations, involving significant contact with employees, subcontractors and suppliers at all levels. The ability to communicate professionally with external contacts and co-workers is essential.

To fulfil this role you will hold a degree or equivalent in a Life Sciences discipline. You will have a strong aptitude and interest for quality and at least 5 years Quality Assurance Management experience.