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Sterilisation Expert, Medical Devices, Contract, Switzerland
Eingestellt von Michael Bailey Associates - UK Contracts
Gesuchte Skills: Client, Consultants
Projektbeschreibung
STERILITY ASSURANCE SPECIALIST, 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 GAMMA 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 sterilization (eg EN ISO 11137-x, EN ISO 556-2, EN ISO 11135) and microbiological control of medical devices.
* AT LEAST 5 YEARS EXPERIENCE IN GAMMA VALIDATION, PREFERENCE WITH METAL AND PLASTIC MEDICAL DEVICES.
* 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
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 and there is a likelihood of the contract extending into 2016.
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.
Kind regards,
Neha Sharma
MBA Michael Bailey Associates
Job Code: 106393
Key words: Sterilisation, Mikrobiologe, microbiologist, Steril, medizinprodukt, freelancer, class III, ISO, EN, CE, FDA, ETO, Gamma, ISO 14971, ISO 13485, regulatory affairs, validation, compliance, regulatory engineer, bioengineer, regulatory compliance, implantable, EN ISO 11137-x, EN ISO 11135, Medical Device Directive, MDD, AAMI standards/reports, sterile devices, Gamma sterilisation, metal, plastic
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
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 GAMMA 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 sterilization (eg EN ISO 11137-x, EN ISO 556-2, EN ISO 11135) and microbiological control of medical devices.
* AT LEAST 5 YEARS EXPERIENCE IN GAMMA VALIDATION, PREFERENCE WITH METAL AND PLASTIC MEDICAL DEVICES.
* 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
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 and there is a likelihood of the contract extending into 2016.
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.
Kind regards,
Neha Sharma
MBA Michael Bailey Associates
Job Code: 106393
Key words: Sterilisation, Mikrobiologe, microbiologist, Steril, medizinprodukt, freelancer, class III, ISO, EN, CE, FDA, ETO, Gamma, ISO 14971, ISO 13485, regulatory affairs, validation, compliance, regulatory engineer, bioengineer, regulatory compliance, implantable, EN ISO 11137-x, EN ISO 11135, Medical Device Directive, MDD, AAMI standards/reports, sterile devices, Gamma sterilisation, metal, plastic
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Organisation/Management