The quality systems specialist ii – sap quality data management

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose. 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.

Job Description

Quality Systems Specialist II – SAP Quality Data Management

Position Summary

The Quality Systems Specialist II – SAP Quality Data Management 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.

Key Responsibilities

SAP Quality Management (QM) Support & Optimization

• 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.

ERP Integration & Digital Transformation

• 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.

Quality Systems & Compliance

• 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.

Process Improvement & Analytics

• Analyze quality and operational data to identify improvement opportunities.
• Drive standardization of quality processes across functional areas and sites.

Validation & Testing

• 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.

Training & Stakeholder Support

• 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.

Required Qualifications

Education

• Bachelor's degree or equivalent experience.

Experience

• 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.

Technical Skills

• 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.

Preferred Qualifications

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

Competencies

• 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.

Key Performance Indicators (KPIs)

• 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.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.