Process Excellence and Digital QMS Quality Partner

hace 7 días

España Roche A tiempo completo

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.
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.
Role Purpose
As a Digital QMS 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 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 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 partners 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'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.

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 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

#J-18808-Ljbffr

  • Senior IT Business Analyst

    hace 6 días

    España Galderma S.A. A tiempo completo

    Senior IT Business Analyst - eDMS and QMSGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and...

  • Senior IT Business Analyst – eDMS and QMS

    hace 7 días

    España Galderma A tiempo completo

    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...

  • Senior IT Business Analyst

    hace 7 días

    España Galderma A tiempo completo

    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...

  • Quality Systems Engineer

    hace 7 días

    España oilandgas.org.uk A tiempo completo

    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 customer...

  • Digital Talent Acquisition

    hace 5 días

    España Merlin Digital Partner A tiempo completo

    Merlin Digital Partner is a tailor-made digital recruitment company for startups, scale-ups and corporates. We were born in Tech Barcelona where we established one of our main offices. We are a dynamic and young team, tech & digital lovers, and truly committed with our candidates. We really believe in long-term relationships and not only in technical...

  • Quality Systems Manager

    hace 7 días

    España Albelli A tiempo completo

    About the role As a Quality Systems Manager at Albelli Photobox Group, you will play a pivotal role in fostering a culture of continuous improvement and a commitment to quality and occupational health & safety (OH&S) across our multinational manufacturing sites. Working within the Industrial Engineering & Planning function, you will collaborate closely with...

  • Design Quality Partner

    hace 5 días

    España F. Hoffmann-La Roche Gruppe A tiempo completo

    Roche 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,...

  • QMS Manager

    hace 5 días

    España Centrient Pharmaceuticals Netherlands A tiempo completo

    Centrient 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 commitment...

  • Design Quality Partner

    hace 4 días

    España Roche A tiempo completo

    Roche 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 7 días

    España F. Hoffmann-La Roche Gruppe A tiempo completo

    Roche 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,...

  • Finance Excellence Partner

    hace 7 días

    España F. Hoffmann-La Roche Gruppe A tiempo completo

    Roche 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,...

  • Quality Assurance Technician

    hace 4 días

    España Straumann Group A tiempo completo

    The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Medentika, Neodent, NUVO, Straumann and other...

  • Quality Assurance Technician

    hace 5 días

    España Institut Straumann AG A tiempo completo

    The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Medentika, Neodent, NUVO, Straumann and other...

  • Quality Assurance Technician

    hace 7 días

    España Straumann Group A tiempo completo

    The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Medentika, Neodent, NUVO, Straumann and other...

  • Senior Quality Specialist

    hace 7 días

    España Takeda A tiempo completo

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Senior Quality Specialist

    hace 7 días

    España Takeda Pharmaceutical A tiempo completo

    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Design Quality Partner

    hace 7 días

    España F. Hoffmann-La Roche AG A tiempo completo

    Roche 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,...

  • Quality Systems Analyst

    hace 5 días

    España TE Connectivity Corporation A tiempo completo

    At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.Job OverviewThe Quality Analyst / Quality Systems Lead is the Quality Systems Representative for this location. This role is responsible for ensuring that all quality-related activities are being performed...

  • Quality Systems Analyst

    hace 7 días

    España TE Connectivity A tiempo completo

    The Quality Analyst / Quality Systems Lead is the Quality Systems Representative for this location. This role is responsible for ensuring that all quality-related activities are being performed according to the QMS procedures and must have a working knowledge of Quality Assurance and Quality Control. Candidates from all industries are invited to...

  • Quality Assurance Technician

    hace 2 días

    España Straumann Group A tiempo completo

    The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, Clear Correct, Medentika, Neodent, NUVO, Straumann and other...