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SAP Quality Management Specialist

Date: Sep 10, 2024

Req ID: 3642

Location:

Somerset, NJ, US, 08873

Company: Terumo Americas Holding, Inc.

Department: SAP Leadership & COE

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

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

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Nearest Major Market: New Jersey