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Sterility Assurance Specialist Sterile Devices
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support, Consultant
Projektbeschreibung
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.
-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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management, Sonstiges