SAP QM Architect

The SAP Quality Management (QM) Architect leads the design, implementation, and optimization of SAP QM solutions in a regulated medical device manufacturing environment. The role requires deep expertise in QM processes, strong cross-module integration skills, and hands-on experience across implementations, rollouts, and upgrades. The architect ensures quality processes meet FDA/ISO standards and seamlessly integrate with manufacturing, supply chain, and compliance systems.

Responsibilities:

• Lead the design, implementation, and optimization of SAP QM solutions in a regulated medical device manufacturing environment.
• Ensure quality processes meet FDA/ISO standards and seamlessly integrate with manufacturing, supply chain, and compliance systems.
• Provide expertise in QM processes and cross-module integration (MM, PP, PP-PI, EWM, PM).
• Collaborate with stakeholders to understand business requirements and provide solutions that meet their needs.
• Manage implementations, rollouts, and upgrades of SAP QM solutions.
• Ensure regulatory compliance (GxP, FDA, ISO 13485) in all aspects of QM processes.
• Integrate MES systems with SAP QM solutions.
• Provide training and support to end-users on SAP QM processes and systems.
• Stay current on industry trends and best practices in SAP QM and quality management.

Requirements:

• 12+ years of SAP experience with a strong focus on SAP QM.
• Proven experience in implementations, rollouts, and upgrades.
• Deep understanding of medical device or life sciences quality processes.
• Strong cross-module integration knowledge (MM, PP, PP-PI, EWM, PM).
• Experience with regulatory compliance (GxP, FDA, ISO 13485).
• Excellent communication and stakeholder management skills.
• Experience with MES integration.