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Drug Delivery Systems Quality Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Design, Support
Projektbeschreibung
REFERENZNUMMER:
326759/11
IHRE AUFGABEN:
-Act as quality management representative in development projects for delivery systems for injectable drugs (drug injectors, reconstitution systems, connected devices)
-Lead the qualification and monitoring of suppliers
-Identify applicable quality and regulatory requirements
-Review and approve training, promotional and labelling material
-Participate in design reviews
-Support regulatory submissions worldwide, especially in the US
-Ensure compliance of design control and maintenance processes to applicable regulations/standards and the company global policies and standards
IHRE QUALIFIKATIONEN:
-Extensive experience in combination products
-Molding knowledge
-Supplier management experience
-Knowledge of CE marking
-Design control process know-how
-Know-how regarding 21 CFR 4 / 820, ISO 13485, ISO 14971, Medical Device Directive 93/42
-Fluency in English
WEITERE QUALIFIKATIONEN:
Quality manager
326759/11
IHRE AUFGABEN:
-Act as quality management representative in development projects for delivery systems for injectable drugs (drug injectors, reconstitution systems, connected devices)
-Lead the qualification and monitoring of suppliers
-Identify applicable quality and regulatory requirements
-Review and approve training, promotional and labelling material
-Participate in design reviews
-Support regulatory submissions worldwide, especially in the US
-Ensure compliance of design control and maintenance processes to applicable regulations/standards and the company global policies and standards
IHRE QUALIFIKATIONEN:
-Extensive experience in combination products
-Molding knowledge
-Supplier management experience
-Knowledge of CE marking
-Design control process know-how
-Know-how regarding 21 CFR 4 / 820, ISO 13485, ISO 14971, Medical Device Directive 93/42
-Fluency in English
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland