Process Excellence and Digital Quality Management Partner
hace 2 días
We are seeking a highly skilled Digital QMS Quality Partner to join our team at Roche. As a key member of our organization, you will play a critical role in ensuring the quality of our products and services.
Key Responsibilities- Quality Management System Implementation and Maintenance
Contribute to the implementation and maintenance of the Quality Management System for Roche Information Solutions (RIS), which consists of a portfolio of standalone software for medical or health purposes.
- Quality Management of Documents and Processes
Manage documents, processes, and support for audits and certifications applicable to RIS products.
- Compliance Activities
Contribute to compliance activities required by regulations and standards for In-Vitro Diagnostics and Medical Device Manufacturers of standalone software products to assure a sustainable state of compliance.
- Continuous Improvement and Integration
Participate in continuous improvement, integration, harmonization of the Quality Management System, Management Review preparation, key performance indicators, Audit and Inspection readiness, and Change Management.
- Collaboration and Partnership Building
Build and maintain strong partnerships with colleagues and business partners to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
Requirements- 2-5 years of working experience
- Bachelor's/Master's degree in Life Science, Data Science, or related subject or equivalent experience.
- Knowledge of Regulations and Quality Management Systems in Health Care (Pharmaceutical or Medical Devices).
- Specific knowledge on ISO13485, ISO14971, IEC62304, IEC 82304, and legislation for software as medical device will be an advantage.
- Able to initiate daily activities independently with limited guidance or supervision.
- Good communication skills.
- Has courage to make decisions within the scope of responsibility.
- Is able to drive innovation within their own area of influence.
- Is able to contribute by participating in large/global cross-functional or cross-chapter squads where it may take a leading role.
- Proficient user of IT tools.
- Advanced level of English. Other languages are an advantage.
- Fascinating opportunities for your professional growth.
- Additional holidays per labor agreement.
- Wide range of options and platforms for learning and development.
- Agile and flexible working policy, working from home.
- An exceptional and modern office space (canteen, parking, and free coffee).
- Private medical insurance.
- Pension plan.
- Life insurance.
- Roche stock options.
We are a global organization with a passion for transforming patients' lives. We are committed to scientific rigor, unassailable ethics, and access to medical innovations for all. Quality is a competitive advantage for us, and we strive to deliver high-quality products to patients, ensure our right to operate, and create value through process excellence and continual improvement efforts.
We believe in diversity and inclusion, and we have a special interest in integrating people with disabilities into our teams. If you have a disability, we encourage you to join us and take advantage of our special benefits.
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