Quality Engineer – Quality ERP Integration (SAP Quality Module)

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Quality Engineer – Quality ERP Integration is responsible for the design, implementation, optimization, and support of quality processes within SAP ERP systems, with a primary focus on the SAP Quality Management (QM) module. This role serves as the bridge between Quality, Manufacturing, Supply Chain, Regulatory, and Information Technology teams to ensure quality requirements are effectively translated into system functionality and data-driven business processes.

The successful candidate will leverage their expertise in quality systems, SAP Quality Management, and process improvement to drive ERP integration initiatives, support business transformation projects, improve compliance, and enhance operational effectiveness across the organization.

• Serve as the subject matter expert (SME) for SAP Quality Management (QM) processes and functionality.

• Configure, maintain, and improve SAP QM master data and process workflows including:

  • Inspection Planning

  • Inspection Lots

  • Quality Notifications

  • Quality Certificates

  • Results Recording

  • Usage Decisions

  • Supplier Quality Management

• Support integration of SAP QM with:

  • Materials Management (MM)

  • Production Planning (PP)

  • Warehouse Management (WM/EWM)

  • Sales and Distribution (SD)

  • Plant Maintenance (PM)

• Collaborate with business stakeholders to gather requirements and translate them into SAP solutions.

• Lead and support ERP integration projects involving quality systems and business processes.

• Participate in SAP implementation, upgrade, validation, migration, and enhancement projects.

• Support the deployment of SAP S/4HANA quality management capabilities and best practices.

• Develop functional specifications and partner with technical teams on system enhancements.

• Evaluate opportunities to automate quality processes through ERP capabilities and digital solutions.

• Ensure SAP quality processes support applicable regulatory and quality management system requirements.

• Partner with Quality Assurance teams to align ERP workflows with:

  • ISO 9001

  • GMP/GxP requirements

  • FDA regulations (as applicable)

  • Industry-specific quality standards

• Support audit readiness activities and provide documentation related to ERP-controlled quality processes.

• Maintain data integrity and compliance within SAP quality-related records.

• Analyze quality and operational data to identify improvement opportunities.

• Drive standardization of quality processes across functional areas and sites.

• Develop and execute User Acceptance Testing (UAT) protocols for SAP QM enhancements and integrations.

• Support system validation activities, including:

  • Requirements documentation

  • Risk assessments

  • Test script development

  • Validation execution

  • Change control documentation

• Ensure all system changes comply with company quality and validation procedures.

• Train end users on SAP QM functionality and business processes.

• Develop standard operating procedures (SOPs), work instructions, and training materials.

• Provide Level 2/Level 3 functional support for quality-related SAP issues.

• Act as a liaison between Quality, Operations, Supply Chain, and IT teams.

• Experience with SAP S/4HANA implementations or transformations.

• Experience supporting FDA-regulated, medical device, pharmaceutical, biotechnology, or manufacturing environments.

• Knowledge of Computer System Validation (CSV) and GxP requirements.

• Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, Information Systems, Life Sciences, or a related discipline.

• Minimum 5 years of professional experience in Quality Engineering, Quality Systems, Manufacturing Quality, ERP Systems, or related fields.

• Minimum 5 years of SAP experience, including hands-on experience with SAP Quality Management (QM).

• Experience participating in SAP implementation, enhancement, migration, or support projects.

• Experience working within regulated manufacturing or quality-driven environments.

• Strong knowledge of SAP Quality Management (QM) module.

• Understanding of SAP ERP or SAP S/4HANA architecture and integration points.

• Familiarity with SAP MM, PP, EWM/WM, SD, and PM modules.

• Experience with reporting and analytics tools such as SAP Fiori, SAP BW, Power BI, or similar platforms.

• Strong understanding of ERP validation and change management processes.

• Strong analytical and problem-solving skills.

• Ability to translate business requirements into system solutions.

• Excellent communication and stakeholder management skills.

• Strong project management and organizational abilities.

• Ability to work independently and manage multiple priorities.

• Continuous improvement mindset with a focus on operational excellence.

• Strong attention to detail and commitment to data integrity.

• SAP QM process effectiveness and system adoption.

• On-time completion of ERP integration and enhancement projects.

• Quality data accuracy and integrity.

• User satisfaction and training effectiveness.

• Continuous improvement and process optimization outcomes.