Onsite SAP Implementation Lead for Regulated Med Device

QRC; Cidra (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

QRC Group, LLC is seeking an experienced SAP Implementation Support Specialist to join our regulatory-focused manufacturing environment in the United States. You will act as on-site SAP SME, drive successful deployment, validation activities, training, and user readiness during go-live and hypercare.

Ideal candidates bring hands-on SAP implementation experience, solid knowledge of GxP, and proven ability to train users while maintaining compliance with FDA and ISO 13485 requirements.

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 FDA/ISO compliance requirements and CSV/documentation.
• Proven experience delivering end-user training in regulated environments.
• Fluent in English; Spanish strongly preferred.
• Onsite availability during go-live and hypercare periods.

Responsibilities

• Provide on-site SAP implementation and validation support.
• Support IQ/OQ/PQ and CSV requirements.
• Assist with UAT and defect resolution.
• Train end users and ensure user readiness.
• Ensure SAP processes align with FDA/ISO requirements.
• Create training materials, WIs, SOPs, and job aids.
• Provide end-user support during go-live and hypercare.
• Coordinate with IT and external SAP partners.

Skills

GxP knowledge

End-user training

Regulatory compliance

Communication

English fluency

Spanish preferred

Education

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

Tools

SAP MM

SAP PP

SAP QM

SAP WM

SAP SD

SAP FI/CO

Job description

QRC Group, LLC is seeking an experienced SAP Implementation Support Specialist to join our regulatory-focused manufacturing environment in the United States. You will act as on-site SAP SME, drive successful deployment, validation activities, training, and user readiness during go-live and hypercare.

Ideal candidates bring hands-on SAP implementation experience, solid knowledge of GxP, and proven ability to train users while maintaining compliance with FDA and ISO 13485 requirements.