Process Excellence and Digital QMS Quality Expert
hace 3 semanas
About the Role
We are seeking a highly skilled and experienced Quality Management System Specialist to join our team at Roche. As a Digital QMS Quality Partner, you will play a critical role in ensuring the quality and compliance of our products and services.
Key Responsibilities
- Contribute to the implementation and maintenance of the Quality Management System for Roche Information Solutions (RIS), including a portfolio of standalone software for medical or health purposes.
- Quality management of documents, processes, and support for audits and certifications applicable to RIS products.
- Contribute to compliance activities required by regulations and standards for In-Vitro Diagnostics and Medical Device Manufacturers of standalone software products to ensure a sustainable state of compliance.
- Participate in continuous improvement, integration, harmonization of the Quality Management System, Management Review preparation, key performance indicators, Audit and Inspection readiness, and Change Management.
- Participate in regional or global cross-functional meetings/initiatives where you may take a leading role.
- Interface with colleagues from Quality, Regulatory, including auditing and post-market Chapters, R&D, Supplier Quality, and Training Chapter to perform the job.
- Build and maintain strong partnerships with colleagues and business partners to ensure alignment around strategic projects and day-to-day activities and to ensure 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.
- Courage to make decisions within the scope of responsibility.
- Ability to drive innovation within your own area of influence.
- Ability to contribute by participating in large/global cross-functional or cross-chapter squads where you may take a leading role.
- Proficient user of IT tools.
- Advanced level of English. Other languages are an advantage.
What We Offer
- 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.
Location
We offer a hybrid model with a lot of flexibility between the Sant Cugat del Valles office and the home office.
At Roche
We are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient's right and every employee's responsibility.
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