SAP Implementation Support Specialist

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! We are seeking a SAP Implementation Support Specialist to support the deployment of SAP within a regulated medical device manufacturing environment. This individual will serve as the on-site SAP subject matter expert (SME), ensuring successful system implementation, user readiness, and compliance with industry regulations (e.g., FDA, ISO 13485). The ideal candidate has hands-on SAP implementation experience, strong knowledge of GxP environments, and proven ability to train users and support change adoption during critical go-live phases. Key Responsibilities -SAP Implementation & Validation Support - Provide on-site SAP support during implementation, testing, and go-live - Support validation activities (IQ/OQ/PQ) in alignment with CSV (Computer System Validation) requirements - Assist with User Acceptance Testing (UAT) and defect resolution - Ensure SAP processes align with regulatory and quality requirements-Training & User Readiness - Develop and deliver training tailored to medical device operations (production, quality, warehouse) - Create compliant documentation: Work Instructions (WIs), SOPs Job aids and training materialsm Coach end users on SAP transactions and best practices-End-User Support (Hypercare) -  Act as first-line SAP support during go-live and stabilization phase - Troubleshoot issues related to transactions, master data, and workflows - Escalate technical issues and coordinate with IT and external SAP partners-Regulatory & Quality Compliance - Ensure SAP usage complies with:o FDA 21 CFR Part 820 / Part 11 o ISO 13485 o Data integrity and audit trail requirements - Support audit readiness and documentation integrity-Process Alignment & Continuous Improvement - Identify gaps between business processes and SAP system functionality - Recommend process improvements aligned with medical device compliance standards - Support post-go-live optimization efforts Required Qualifications - Bachelor’s degree in Engineering, Information Systems, Life Sciences, or related field - 3–6 years of SAP experience, including at least one full implementation - Experience in medical device, pharmaceutical, or regulated manufacturing environment - Strong knowledge of at least one SAP module (MM, PP, QM, WM, SD, or FI/CO) - Experience supporting Computer System Validation (CSV) and documentation - Proven experience delivering end-user training in a regulated environment - Working knowledge of FDA and ISO compliance requirements - Strong troubleshooting, communication, and interpersonal skills - Fluent in English (Spanish strongly preferred) - Onsite administrative shift (availability to work extended hours during go-live and hypercare period)Preferred Qualifications - SAP S/4HANA experience - SAP certification (any module) - Experience with quality management processes (CAPA, NCR, traceability, batch/lot control) - Familiarity with electronic records and audit trails (21 CFR Part 11) All your information will be kept confidential according to EEO guidelines.