Process Excellence and Digital QMS Quality Partner
hace 7 meses
The Position
Who We Are
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.
Qualityis 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.
Role Purpose
As a Digital QMS Quality Quality Partner you are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and the We@Roche Diagnostic Commitments. You are responsible for building and developing your capabilities to contribute more to the team, customers and patients. You apply new approaches to improving your work to enhance established processes, reduce costs or mitigate significant compliance issues within your area of influence. You work as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.
You will be responsible to
Contribute to implement and maintain the Quality Management System for Roche Information Solutions (RIS), which consists of a portfolio of stand alone 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 stand-alone software products to assure 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 it 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 patterns to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
Additional tasks:
Can 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.
Identifying and escalating issues as they arise and able to provide adequate solutions.
What else do you have in your toolbox:
2-5 years of working experience
Bachelor’s / Master 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 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
Locations:
We offer a hybrid model with a lot of flexibility between the Sant Cugat del Valles office and the home office.
What else:
This role offers a competitive salary, plus an excellent benefits package that includes (among others):
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 optionsPlease 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
-
Process Excellence and Digital QMS Quality Partner
hace 2 meses
Sant Cugat del Vallès, España Roche A tiempo completoThe Position Who We Are 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...
-
Digital Quality Excellence Specialist
hace 4 semanas
Sant Cugat, Barcelona, España Roche A tiempo completoCompany Overview">At Roche, we are committed to transforming patients' lives through our passion for scientific rigor, unassailable ethics, and access to medical innovations. Our quality management system is a competitive advantage that enables us to deliver high-quality products, ensure our right to operate, and create value through process excellence and...
-
Design Quality Partner
hace 1 mes
Sant Cugat del Vallès, España Roche A tiempo completoRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Design Quality Partner
hace 3 semanas
Sant Cugat del Vallès, España Roche A tiempo completoRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Design Quality Partner
hace 2 meses
Sant Cugat del Vallès, España F. Hoffmann-La Roche Gruppe A tiempo completoRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Design Quality Partner
hace 3 semanas
Sant Cugat del Vallès, España Roche A tiempo completoRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Design Quality Partner
hace 3 semanas
Sant Cugat del Vallès, España F. Hoffmann-La Roche Gruppe A tiempo completoRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Design Quality Partner
hace 2 meses
Sant Cugat del Vallès, España F. Hoffmann-La Roche Gruppe A tiempo completoRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Design Quality Partner
hace 2 meses
Sant Cugat del Vallès, España F. Hoffmann-La Roche AG A tiempo completoRoche fosters diversity, equity, and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Design Quality Partner
hace 3 semanas
Sant Cugat del Vallès, España F. Hoffmann-La Roche AG A tiempo completoRoche fosters diversity, equity, and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Design Quality Partner
hace 2 meses
Sant Cugat del Vallès, España F. Hoffmann-La Roche AG A tiempo completoRoche fosters diversity, equity, and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Head of Quality Medicine Spain
hace 7 meses
Sant Cugat del Vallès, Barcelona provincia, España Boehringer Ingelheim España, S.A. A tiempo completoThe Head of Quality Medicine defines, shapes and leads the Medicine Quality Management System (QMS) in the country consistently, based on and in accordance with the global Boehringer Ingelheim Medicine QMS throughout drug development to maximize patient safety, data integrity, fast and efficient market authorizations and maintenance of our licenses. **Tasks...
-
Quality Systems Engineer
hace 2 semanas
Sant Boi de Llobregat, España Schneider Electric A tiempo completoJob Description: The Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and...
-
Quality Systems Engineer
hace 2 semanas
Sant Boi de Llobregat, España Schneider Electric A tiempo completoJob Description:The Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and...
-
Quality Systems Engineer
hace 3 semanas
Sant Boi de Llobregat, España Schneider Electric Global A tiempo completoThe Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and customer...
-
Quality Systems Engineer
hace 2 semanas
Sant Boi de Llobregat, España Schneider Electric Global A tiempo completoThe Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and customer...
-
Quality Systems Engineer
hace 3 semanas
Sant Boi de Llobregat, España Schneider Electric Global A tiempo completoThe Quality Systems Engineer is responsible for developing, implementing, and maintaining the quality management systems (QMS) across the plant and modular data center operations. This role will emphasize training teams on quality processes and implementing continuous improvement initiatives that ensure compliance with industry standards and customer...
-
Qms Manager
hace 4 meses
Sant Feliu de Llobregat, España Centrient Pharmaceuticals Netherlands A tiempo completoCentrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms. We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our...
-
Technical Quality Manager
hace 4 semanas
Sant Boi de Llobregat, Barcelona, España oilandgas A tiempo completoWe are looking for an accomplished Technical Quality Manager to lead our quality management efforts in the oil and gas industry. As a key member of our team, you will be responsible for developing and implementing quality management systems (QMS) in accordance with ISO 9001, AS9100, or similar standards.You will work closely with cross-functional teams to...
-
Head of product
hace 2 meses
Sant Cugat del Vallès, España Merlin Digital Partner A tiempo completoWe are Merlin Digital Partner, a leading IT and digital headhunting company with over a decade of experience. We've successfully collaborated with industry heavyweights such as Wallapop, Glovo, Banc Sabadell, and Factorial.Our emphasis lies in people-centric approaches and optimizing selection processes. Our mission is to revolutionize companies by...