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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.

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

 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.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.