About the Job

Description:

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.

Role overview :

The SAP QM Architect is responsible for defining the end-to-end QualityManagement solution architecture within SAP S/4HANA. This includes designing compliant QM processes, integrating them with production and supply chainmodules, and partnering with business teams to ensure high-quality, audit ready operations. The role demands excellent communication skills to translate complex quality requirements into scalable SAP solutions.

Key Responsibilities:

Lead end to end 'end SAP QM solution architecture for medical
device manufacturing environments
Design, configure, and optimize core QM processes: inspection planning, in process/final inspections, results recording,
usage decisions, notifications, and defect management.
Ensure SAP QM processes comply with FDA, ISO
13485, GxP, and other regulatory requirements
Drive SAP implementation, rollout projects across
global manufacturing sites
Conduct requirement gathering, fit?€'gap analysis, and blueprint creation for QM
processes
Integrate QM with MM, PP/PP?€'PI, EWM/WM, PM, SD, and external systems such as
LIMS/MES
Develop and maintain validation documentation:
IQ/OQ/PQ, SOPs, test scripts, and process flows
Collaborate with Quality, Manufacturing, Supply
Chain, and IT stakeholders to align solutions
Provide functional specifications, guide
technical teams, and oversee development activities
Lead testing cycles (SIT/UAT), cutover planning,
and post 'live hypercare
Identify process improvement opportunities and
drive standardization across sites
Required Skills & Experience

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, EWM, PM).
Experience with regulatory compliance (GxP, FDA,
ISO 13485).
Excellent communication and stakeholder
management skills.
Experience with MES integration

Required Skills

• SAP QM