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E-Device Quality Consultant (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Design, Consultant
Projektbeschreibung
REFERENZNUMMER:
336139/11
IHRE AUFGABEN:
-Be the primary quality contact point for electromechanical medical devices (i.e. drug auto-injectors and connected accessories)
-Ensure design control compliance
-Identify applicable quality requirements and applicable standards
-Review and approve all project deliverables (internal and from suppliers)
-Participate in design reviews, approve/disapprove move to next phase
-Compile the Technical File, ensure CE mark approval
-Support medical device regulatory submissions worldwide
-Lead and execute the telecommunication registrations activities worldwide
-Lead the change control process
IHRE QUALIFIKATIONEN:
-Business fluency in English
-Very good knowledge in electromechanical device industry and medical device industry
-Knowledge in ISO 13485 / 21 CFR 820, MDD 93/42/EEC and RED, RoHS2, WEEE2 Directives
WEITERE QUALIFIKATIONEN:
Quality manager
336139/11
IHRE AUFGABEN:
-Be the primary quality contact point for electromechanical medical devices (i.e. drug auto-injectors and connected accessories)
-Ensure design control compliance
-Identify applicable quality requirements and applicable standards
-Review and approve all project deliverables (internal and from suppliers)
-Participate in design reviews, approve/disapprove move to next phase
-Compile the Technical File, ensure CE mark approval
-Support medical device regulatory submissions worldwide
-Lead and execute the telecommunication registrations activities worldwide
-Lead the change control process
IHRE QUALIFIKATIONEN:
-Business fluency in English
-Very good knowledge in electromechanical device industry and medical device industry
-Knowledge in ISO 13485 / 21 CFR 820, MDD 93/42/EEC and RED, RoHS2, WEEE2 Directives
WEITERE QUALIFIKATIONEN:
Quality manager
Projektdetails
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Organisation/Management
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland