Digital Quality Excellence Partner
hace 6 días
The Role
At Roche, we are committed to delivering high-quality products to patients and ensuring our right to operate. As a Digital QMS Quality Partner, you will play a crucial role in building and developing capabilities to contribute to the team, customers, and patients. You will apply new approaches to improve work, enhance established processes, reduce costs, and mitigate significant compliance issues within your area of influence.
Your Responsibilities
- Contribute to the implementation and maintenance of the Quality Management System for Roche Information Solutions (RIS), which includes 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.
Additional Tasks
- Coach and train quality professionals with less experience and provide guidance.
- Collaborate to audit readiness for internal and external audits.
- Act as a learning expert in defining and maintaining all required training according to the roles and responsibilities.
- Support in change control methodology and documentation.
- Support investigation or documentation of non-conformities or CAPA.
- Identify and escalate issues as they arise and provide adequate solutions.
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 Healthcare (Pharmaceutical or Medical Devices).
- Specific knowledge on ISO13485, ISO14971, IEC62304, IEC 82304, and legislation for software as a 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 you may take a leading role.
- Proficient user of IT tools.
- Advanced level of English. Other languages are an advantage.
What We Offer
We offer a competitive salary, plus an excellent benefits package that includes:
- 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.
Please check the following link to know more about our benefits.
As this position is part of a global organization, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.
At Roche, diversity and inclusion are essential values for our success. We have a special interest in integrating people with disabilities into our teams. If you have a disability, for us it is a plus, and we have special benefits for you: Go ahead and join us.
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