Job Summary

The SAP Quality Management Specialist will collaborate with business stakeholders, consultants to help design, develop, deploy and support solutions in SAP S/4HANA and any associated bolt-ons to meet business unit needs for “Quality Management” business processes. The incumbent will also play a critical role in supporting the developing the architecture and implementation of SAP S4HANA within the operating subsidiaries and the holding company for Terumo in North and South America.

Job Details/Responsibilities

• Responsible for developing standard business process design, configure, test, deploy and support SAP S/4HANA solution along with any bolt-on for all “Quality Management Processes” across Production, Procurement and distribution functions.
• Act as main design and support authority for the Quality Management team in collaboration with Business stakeholders.
• Take ownership for the Global Process Design Template, Configuration, Test Scripts and other associated work products related to “SAP Quality Management processes” to ensure effective control over changes required for localization or legal requirements.
• Respond to User Help Desk tickets for disposal of service requests from business users.
• Enhance Quality Management business processes through the development of regionally relevant solutions to meet business needs.
• Drive the Functional Integration of SAP Quality management process with all E2E processes enabled by SAP S/4HANA to ensure proper design, development and testing.
• Work with other Process Team(s) in resolving key integration points between and across processes to ensure they are properly accounted for.
• Utilize and build on basic knowledge in areas such as IDOCs, batch job processing to troubleshoot and suggest improvements.
• Perform Fit/Gap assessment and finalize functional specifications for Quality management business process and develop design specification to close the gap in business process.
• Perform unit testing and ensure satisfaction of the documented requirements with user in SAP quality management process.

Knowledge, Skills and Abilities (KSA)

• Medical Device/Serialized product experience is required
• Some familiarity with FDA CFR Part 11 Software Validation processes
• Keen analytical skills
• Keen sense of maturity, judgment and diligence required to:
• Secure company’s financial interests; and,
• Avoid exposures to expensive delays and cost overruns.
• Strong inter-personal and communication skills
• Ability to cope with stress and continuously changing demands/priorities
• Willingness to learn new skills/techniques/processes
• Good knowledge on SAP QM related configuration based on the requirements to map in SAP.
• Additionally Plant maintenance and Calibration experience is preferred but not required skill for this position.
• Should have good knowledge in Batch Management process and batch determination.
• Should have good understanding of incoming inspection, inspection with production process along with integration with EWM-QM settings.
• Experience in Business Process Finalization, Fit-Gap Analysis, Customization, Incorporation of enhancements & new requirements, Integration Issue resolution.
• Experience in sample determination using different sampling procedures.
• Good experience in Production Support with resolving user issues and coordinating user testing activities, creation, and processing of change management activities.
• Work with other Process Team(s) in resolving key integration points between and across processes to ensure they are properly accounted for.
• Basic knowledge in areas such as IDOCs, batch job processing to troubleshoot and suggest improvements

Qualifications/ Background Experiences

• Bachelor’s degree in any process area, (e.g., Finance, Supply Chain, etc.) with professional certification preferably in SAP (e.g., SAP Supply Chain)
• Minimum 8 years of experience with progressive increase in responsibilities in Global Process Design, Deployment and/or support experience utilizing and configuring the SAP Production Planning, Quality Management, Plant Logistics (IM/WM) and Plant Maintenance modules with a heavy focus in Production Planning Master Data (Material Master, Bills of Materials, Routings, Work centers etc), MRP, Production Scheduling, Discrete Manufacturing, Shop-Floor Management, Quality Management (Quality Inspections, Notifications, CAPA) in Production, Procurement and Distribution processes and Compliance, Batch Management, Serialization, Batch Traceability, Quality Certifications / Labelling as well as Integrating to MES & QMS solutions
• Multiple Years of Experience in Medical Device / Life Sciences Industry is preferable.
• Major large, complex multi country end to end SAP transformation programs preferable