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Archiviertes Projekt - Quality Assurance Manager Medical Devices (m/f/d)

Firmenname für PREMIUM-Mitglieder sichtbar

Januar 2021

Juli 2021


auf Anfrage




Ihre Aufgaben:
• Ensure that internal procedures, applicable regulations and standards (regulatory requirements of FDA, In Vitro Diagnostics Directive of the EU, ISO 13485, etc.) are followed during manufacturing of plastic injection molding parts (Consumables)
• Support and enable supplier during increasing production volumes, product care and product improvement activities in all other quality aspects of consumables products
• Responsible for product quality and compliance to the regulatory requirements and the proper documentation of all activities
• Support suppliers by reviewing and approving documents, changes and deviations
• Reviewing and approving Q&V activities and releasing product
• Ensure improvements through CAPAs, SCARs and process updates
• Lead / support special projects or initiatives in the area of supplier quality 
• Permanently optimize processes in order to increase quality and efficiency standards

Ihre Qualifikationen:
• Academic degree in an engineering or life science discipline
• Thorough practical experience in Quality Management, Quality Assurance or Quality Control
• Professional experience in medical device regulations including ISO 13485 and FDA regulations for the above mentioned processes
• SAP User experience
• First experience in leading process improvement projects
• First experience with stakeholder management across all hierarchy levels
• Injection Molding expertise desired
• Active and initiative personality as well as strong communication skills in both German and English
• Self-dependent, structured, quality-oriented and determined

Ihre Vorteile:
• Working in a fast changing and growing environment in a team of six specialists who cover the quality support for consumables products
• The Quality Assurance department consists of 35 highly motivated people 

Projektdauer: 6 MM++

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