Roche fördert Diversität, Gleichstellung und Inklusion und repräsentiert die Gemeinschaften, denen wir dienen. Wenn es um die Gesundheitsversorgung auf globaler Ebene geht, ist Vielfalt eine wesentliche Zutat für den Erfolg. Wir glauben, dass Inklusion der Schlüssel zum Verständnis der unterschiedlichen Bedürfnisse der Menschen im Gesundheitsbereich ist. Gemeinsam engagieren wir uns für Individualität und teilen die Leidenschaft für eine herausragende Versorgung. Kommen Sie zu Roche, wo jede Stimme zählt.
Die Position
Role Purpose
The Roche Diagnostics International Quality & Regulatory function governs the quality of our medical devices. Our quality assurance team ensures the highest standards for the Qualification, Validation and equipment management activities performed by our business partners. They develop cutting-edge in-vitro medical devices, assays, laboratory information solutions and cloud-based offerings in the medical domain and include R&D, manufacturing and end user service organizations.
The Opportunity:
As a Senior Quality Partner, you will:
* Act as independent Quality representative for qualification & validation business teams
* Enable our business partners to develop and execute compliant and efficient qualification & validation strategies based on our global quality management system
* Perform comprehensive and independent feedback, review and approval of all validation and qualification artifacts involved in the system life cycle
* Based on a deep understanding of our global modular quality management system: act as ambassador and change agent of the global processes and thereby enable our business partners to deliver high class medical products
* Participate in internal and external audits
Who you are:
* Your passion is to achieve highest quality standards while keeping stakeholders happy
* You bring at least 3 years of practical qualification/validation engineering for GxP environments
* You have worked in more than one function within quality management in the area of medical devices or in vitro Diagnostics (based on ISO 13485 and FDA’s Quality Systems Regulations)
* You bring experience and/or know-how in all Qualification & Validation processes
* Technical or scientific degree or completed education in a technical profession
* Autonomous, flexible, agile and open-minded team player with the ability to assert yourself.
* You know how to take controlled risks and are experienced in audit situations
* Ability to manage highly complex and/or global projects (or equivalent experience)
NB: Employees will work across the different campuses.
Wer wir sind
Bei Roche leisten 100,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
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