Quality Assurance Analyst
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.That’s what makes us Roche.
The position
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 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.
Our new global modular quality management brings a radical simplification of our process landscape and provides our validation and qualification teams with more freedom and ability to shape our future, while preserving our high quality standards.
Your responsibilities as a Quality Assurance Manager include, in particular:
- Act as an independent Quality Partner for our qualification & validation business teams
- Perform comprehensive and independent feedback, review and approval of validation and qualification artifacts involved in the system life cycle
- Enable our business partners to develop and execute compliant and efficient qualification & validation strategies based on our global quality management system
- Technical or scientific degree or completed training in a technical profession, combined with at least 1 year of hands-on experience in qualification and/or validation in GxP-regulated environments.
- Experienced in quality management, particularly in equipment qualification or process validation, ideally within medical devices or in vitro diagnostics (ISO 13485, FDA QSR).
- Independent, agile, and open-minded team player with the ability to assert yourself..
- Fluent in both German (used for daily communication and documentation) and English (C1 level or higher; interviews conducted in German).
Apply now and become part of our team to shape the future together!
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products.We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.