Sterilisation Expert, Medical Devices, Contract, Switzerland

STERILISATION EXPERT, NON-STERILE MEDICAL DEVICES, CONTRACT, SWITZERLAND

We have an exclusive Contract opportunity in the canton of Solothurn to lead the sterilisation and registration processes of a global medical device manufacturer for the European region. Our client offers a leading position for European sterility assurance activities and varied responsibilities within regulatory compliance and stakeholder management including the training of colleagues throughout their manufacturing environment. English is the only language requirement for the role.

The role is working on a full time basis, onsite in the canton of Solothurn and pays a competitive Hourly Rate. Please see the following minimum requirements:

- EXPERIENCE IN STEAM STERILISATION IS IMPORTANT
- 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.
- Language: English needed and German would be an advantage

We welcome applications of consultants' who match most of the above requirements and are available on a short notice. Please note there is a job description available on request.

We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this email and I will endeavour to get back to you with further information on the role and answer any questions you may have. Alternatively I am contactable via an open-link on LinkedIn.

Kind regards,

Neha Sharma

MBA Michael Bailey Associates

Job Code: 106392

Key words: steam sterilisation, steam, Sterilisation, Mikrobiologe, microbiologist, Steril, medizinprodukt, freelancer, ISO, EN, CE, FDA, ETO, ISO 14971, ISO 13485, validation, compliance, regulatory engineer, bioengineer, regulatory compliance, Medical Device Directive, MDD, clinical reprocessing, EN ISO EN ISO 15883, EN ISO 17665, EN ISO 17664, RKI guideline, AAMI TIR 12, reprocessing program, non-sterile medical devices, medical devices

Michael Bailey International is acting as an Employment Business in relation to this vacancy.