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Consultant Quality Management (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Consultant
Projektbeschreibung
REFERENZNUMMER:
279484/11
IHRE AUFGABEN:
-Provide support for quality system management
-Creation and update of SOPs
-Management of deviations (CAPAs)
-Documentation control
-Change control
-Maintenance of technical files
-Compilation and update of technical file to support the CE marking of class IIa (mechanical and electronic drug injection systems) and class I (software applications) medical device
-Update of risk management file for ISO 14971, essential requirements check-list and clinical evaluation report
-Collection and review of supplier documents
-Support international submissions
IHRE QUALIFIKATIONEN:
-Good knowledge of quality systems
-Knowledge of ISO13485, 21 CFR 820, GMD guidelines
-Knowledge in CE marking of medical devices
WEITERE QUALIFIKATIONEN:
Quality manager
279484/11
IHRE AUFGABEN:
-Provide support for quality system management
-Creation and update of SOPs
-Management of deviations (CAPAs)
-Documentation control
-Change control
-Maintenance of technical files
-Compilation and update of technical file to support the CE marking of class IIa (mechanical and electronic drug injection systems) and class I (software applications) medical device
-Update of risk management file for ISO 14971, essential requirements check-list and clinical evaluation report
-Collection and review of supplier documents
-Support international submissions
IHRE QUALIFIKATIONEN:
-Good knowledge of quality systems
-Knowledge of ISO13485, 21 CFR 820, GMD guidelines
-Knowledge in CE marking of medical devices
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management, Sonstiges
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland