Quality Excellence and Compliance Specialist
hace 20 horas
At Roche, we prioritize quality as a key driver of our success. We're seeking a highly skilled Digital QMS Quality Partner to join our team.
About the Role
This is an exciting opportunity to contribute to the implementation and maintenance of our Quality Management System (QMS) for Roche Information Solutions (RIS). You will be responsible for ensuring compliance with regulatory requirements, managing documents and processes, and supporting audits and certifications for our standalone software products.
Key Responsibilities
- Contribute to the development and implementation of QMS policies and procedures
- Ensure adherence to regulatory requirements, including ISO13485 and ISO14971
- Manage documents, processes, and support for audits and certifications
- Collaborate with cross-functional teams, including Quality, Regulatory, R&D, and Supplier Quality
- Build strong partnerships with colleagues and business partners to ensure alignment around strategic projects and day-to-day activities
Requirements
- 2-5 years of experience in Quality Assurance or a related field
- Bachelor's/Master's degree in Life Science, Data Science, or a related subject
- Knowledge of regulations and quality management systems in healthcare
- Specific knowledge of ISO13485, ISO14971, IEC62304, and legislation for software as a medical device
- Proficient user of IT tools and advanced level of English
What We Offer
- Competitive salary: €80,000 - €120,000 per year, depending on experience
- Hybrid work model with flexibility between the Sant Cugat del Valles office and home office
- Fascinating opportunities for professional growth and development
- Excellent benefits package, including private medical insurance, pension plan, and life insurance
Working at Roche
We value diversity and inclusion and strive to create an inclusive workplace where everyone feels valued and supported. If you have a disability, we encourage you to apply and offer special benefits to help you succeed in your role.
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