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
Requirements
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)
Skills Required
- 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 (IQ/OQ/PQ)
- Proven experience delivering end-user training in a regulated environment
- Working knowledge of FDA and ISO compliance requirements (e.g., FDA 21 CFR Part 820/Part 11, ISO 13485)
- Strong troubleshooting, communication, and interpersonal skills
- Fluent in English
- Availability to work onsite administrative shift and extended hours during go-live/hypercare
- 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)
- Spanish language skills
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
