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Schlagworte
Beschreibung
Tasks:
Create, review, correct and release any documents to cover the company sterilization program (eg Gamma sterilization Program).
Correspond with internal and external customers with special requests regarding the company sterilization program.
Support and ensure sterility validations (eg dose establishing, dose audits, dose mappings) for all product families are remediated and following the current standards.
Train PD, consultant and other personnel in basic sterilization and in sterilization procedures.
Review all vendor sterility assurance validation protocols and reports to ensure company and regulatory requirements are met.
Create internal validation and re-validation protocol and reports.
Other duties/responsibilities as assigned by manager.
Requirements:
Knowledgeable in applicable Medical Device Directive (MDD), ISO13485, ISO 14971, ISO 9001 and FDA (QSR) regulations.
Well versed in grnment 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
English needed and German would be an advantage
Qualification from collage or higher education
Professional experience for at least 5 years
Are you interested in this position? Then we are looking forward to receiving your application.
Start
keine Angabe
Dauer
31/05/2015
Von
Harvey Nash IT Recruitment Switzerland
Eingestellt
26.02.2015
Projekt-ID:
858541
Vertragsart
Freiberuflich
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