SAP Implementation Support Specialist

QRC Group; Cidra (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

QRC Group in Puerto Rico seeks an SAP Implementation Support Specialist to lead on-site SAP deployment in a regulated medical device environment. You will ensure successful system implementation, user readiness, and compliance with FDA and ISO requirements.

The role requires hands-on SAP implementation, experience in GxP environments, and the ability to train users and support change during go-live and hypercare, with collaboration across IT and quality teams.

Qualifications

• Bachelor's degree in a relevant field is required.
• 3–6 years of SAP experience, including at least one full implementation.
• Experience in medical device, pharmaceutical, or regulated manufacturing environment.
• Fluent in English; Spanish strongly preferred.

Responsibilities

• Provide on-site SAP support during implementation, testing, and go-live.
• Assist with validation activities (IQ/OQ/PQ) in CSV (Computer System Validation) requirements.
• Develop and deliver training tailored to medical device operations (production, quality, warehouse).
• Ensure SAP usage complies with FDA 21 CFR Part 820 / Part 11 and ISO 13485.
• Identify gaps between business processes and SAP functionality and suggest improvements.

Skills

SAP implementation

GxP environments

User training

Stakeholder collaboration

Regulatory compliance

Education

Bachelor’s degree in Engineering, Information Systems, Life Sciences, or related field

Tools

SAP MM

SAP PP

SAP QM

CSV validation

Job description

Cidra, Puerto Rico | Posted on 09/16/2026

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), SOPsJob aids and training materials 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

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)