Onsite SAP Implementation Lead - Regulated Manufacturing

QRC; Cidra (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group, LLC is seeking an SAP Implementation Support Specialist to lead on-site SAP deployment in a regulated medical device environment, ensuring user readiness and compliance with FDA and ISO 13485.

The ideal candidate has hands-on SAP implementation experience, strong GxP knowledge, and the ability to train users and drive change during go-live and hypercare, with collaboration across QA, manufacturing and IT teams.

Qualifications

• Bachelor's degree in a 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.

Responsibilities

• Provide on-site SAP support during implementation, testing, and go-live.
• Support validation activities (IQ/OQ/PQ) in alignment with CSV requirements.
• Assist with User Acceptance Testing (UAT) and defect resolution.
• Ensure SAP processes align with regulatory and quality requirements.
• Develop and deliver training tailored to medical device operations (production, quality, warehouse).
• Create compliant documentation: Work Instructions, SOPs, job aids and training materials.
• Coach end users on SAP transactions and best practices.
• End-User Support (Hypercare) and on-site go-live stabilization.
• Troubleshoot issues related to transactions, master data, and workflows.
• Escalate technical issues and coordinate with IT and external SAP partners.
• Ensure SAP usage complies with FDA 21 CFR Part 820/Part 11 and ISO 13485.

Skills

Regulatory compliance knowledge

Training end users

Communication skills

Interpersonal skills

Problem solving

Education

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

Tools

SAP MM/PP/QM/WM/SD/FI-CO

Job description

QRC Group, LLC is seeking an SAP Implementation Support Specialist to lead on-site SAP deployment in a regulated medical device environment, ensuring user readiness and compliance with FDA and ISO 13485.

The ideal candidate has hands-on SAP implementation experience, strong GxP knowledge, and the ability to train users and drive change during go-live and hypercare, with collaboration across QA, manufacturing and IT teams.