Senior SAP Systems Analyst, Quality Management (SAP QM)

Fresenius Medical Care AG; Morelia; Híbrido; MXN 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care AG is seeking a senior SAP QM/IT architect to support QM applications, PPM and QA within a hybrid Mexico City environment. You will lead QM projects, coordinate with vendors, and drive continuous improvement across QM IT systems.

You will design architectures, manage stakeholders, and ensure alignment with ISO 13485 and GMP standards. Strong SAP QM/S4/HANA and EWM experience required.

Formación

• Bachelor’s or Master’s degree in Computer Science, Engineering, Supply Chain, Industrial Management, or related fields.
• 6–9 years in Quality Management space.
• 4+ years hands-on SAP QM (S/4HANA preferred) and SAP EWM QIE.
• Experience in manufacturing environments across discrete/process industries.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management.
• High level of accuracy and structured working style.
• Capability to adapt in an international and culturally diverse environment.

Responsabilidades

• Project management and Subproject management in the area of implementation of QM applications.
• Independent setup, implementation and optimization of QM reporting from ITS QM to Director/VP level within the quality organization.
• Independent lead of projects / development service providers to achieve project goals.
• Manage processes and service providers related to maintenance activities.
• Designs and develops system architectures and defines key capabilities and performance requirements.
• Makes decisions on moderately complex to complex issues regarding technical approach for project components.
• Interacts with internal stakeholders and external clients/customers.
• Influences internal and external parties to achieve objectives; represent the organization.
• Modifies existing methods, techniques and/or processes across job areas.
• Documentation of design and development activities and results as well as OQ and PQ testing.
• Leading training initiatives for end users in the area of Quality Management.
• Independent identification of process potentials incl. business case creation and realization.
• Execution of the demand and project portfolio management process.
• Independent further development of Quality Management template processes.

Conocimientos

SAP QM

S/4HANA

SAP EWM QIE

Quality Management

Project Management

Stakeholder management

Analytical skills

Communication skills

International environment

ISO 13485 awareness

Educación

Bachelor’s/Master’s in Computer Science, Engineering, Supply Chain, Industrial Management, or related fields

Herramientas

SAP QM

S/4HANA

SAP EWM QIE

Descripción del empleo

This is a HYBRID work environment located in Mexico City

Goal of function:

Offering an architectural framework for the development, maintenance and improvement of the SAP ERP systems of FME. Understands the user and process requirements and assures that these requirements are fulfilled by high quality results. Works closely with developers and business to create roadmaps for applications, align development plans and to assure the effective integration of information systems and the IT infrastructure.

Ensuring appropriate implementation of quality management (QM) business processes based on the requirements of the Fresenius Medical Care business units within the Fresenius Medical Care IT system landscape.

Independent assumption and responsibility for project management tasks and coordination tasks, as well as development and responsibility for the demand management process for the QM area. Ensuring business continuity as well as coordination and independent implementation of continuous improvement processes within the global FME QM business processes.

Analysis of system configurations and parameters that influence QM processes.

Coordination of design and development activities in the area of QM IT systems. The functions form the interface between operational business and IT service providers (e.g. FDT, CAP Gemini, Accenture)

Leading optimization projects in the area of QM IT systems.

Main tasks:

• Project management and Subproject management in the area of implementation of QM applications
• Independent setup, implementation and optimization of QM reporting (demands and incidents) from ITS QM to Director/VP level within the quality organization
• Independent lead of projects / development service providers to achieve project goals according to set expectations
• Manage processes and service providers related to maintenance activities
• Designs and develops system architectures and defines key capabilities and performance requirements. Defines total systems design and technology. Develops system element architecture and designs and interfaces definitions. Develops models and architectural guidelines for current and future system development.
• Makes decisions on moderately complex to complex issues regarding technical approach for project components.
• Interacts with internal stakeholders within own department and departmental management, as well as external stakeholders which may include clients and customers.
• Influences internal and external parties, who regularly have divergent interests, to achieve short-term national and project objectives; represent the organization within area of responsibility.
• Modifies existing methods, techniques and/or processes across job areas.
• Documentation of design and development activities and results as well as OQ and PQ testing
• Leading training initiatives for end users in the area of Quality Management
• Independent identification of process potentials incl. business case creation and realization
• Execution of the demand and project portfolio management process (effort/cost/resources/scheduling)
• Independent further development of Quality Management template processes

KPIs

• Project fulfillment in terms of time, cost and quality
• Completeness of work documentation (design, development, maintenance)
• Timely identification of risks and problems. Initiation of appropriate measures to avoid and prevent risks and problems.
• Complete and regular project reporting
• Feedback from customers and disciplinary superiors

Requirements for the role:

• Bachelor’s/Master’s in Computer Science, Engineering, Supply Chain, Industrial Management, or related fields.
• SAP QM / EWM certification advantageous.
• 6–9 years in Quality Management space
• 4+ years hands‑on SAP QM (S/4HANA preferred) and SAP EWM QIE
• Experience in manufacturing environments across discrete/process industries.
• Strong analytical and problem‑solving skills.
• Excellent communication and stakeholder management.
• High level of accuracy and structured working style.
• Capability to adapt in an international and cultural diverse environment
• Ability to work under pressure and manage operational priorities.
• Technical knowledge
  • Inspection planning
  • Quality Certifcate Handling
  • Supplier Qualification
  • Product and Market Release based on Inspection Lots and Usage Decisions
  • QM-PP–MM–LE integration understanding
  • Excellent knowledge of Quality Management processes
  • Awareness on Quality Management Standards (e.g. ISO 13485, ISO9001,…)
• Basic knowledge about medical devices (MDR 2017/745) and pharmaceutical regulations (GMP, AMG, AMWHV, …)
• Knowledge of application development and implementation
• Business Process Modeling
• Project Management Methods
• Presentation experience