W2 - 12+ SAP Quality Management (QM) Architect-Remote

Location:  Remote
Job Title:  SAP QM architect
Primary Skills:  SAP QM

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