Global Warehouse Quality & Standards Lead

Siemens Healthineers AG; Greendale (WI); On-site; USD 167,000 - 230,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers AG, in Wisconsin, seeks a Quality Programs and Warehouse Quality Oversight Lead to drive global quality frameworks for warehouse operations, service spare parts inspection, and refurbishment programs. You will collaborate with Procurement, Logistics, Supplier Quality, and Engineering to ensure regulatory compliance and scalable quality solutions.

This senior role requires 8+ years in Quality within regulated environments, strong QMS knowledge (ISO 13485, FDA QSR), and travel

Qualifications

• Bachelor’s degree in Engineering, Natural Sciences, Supply Chain, or equivalent (advanced degree preferred).
• 8+ years of experience in Quality, preferably within regulated industries (medical device strongly preferred).
• Experience working with warehouse or 3PL environments and defining/implementing quality requirements or QAAs.
• Experience with supplier quality management, qualification, and oversight activities.
• Strong understanding of QMS and regulatory requirements (ISO 13485, FDA QSR).
• Experience working in cross-functional environments and influencing without direct authority.
• Proficiency with SAP, Excel, and data visualization tools (Power BI).
• Willingness to travel (~15–20%).

Responsibilities

• Warehouse Quality Oversight: Lead development and deployment of global Warehouse Requirements documents.
• Define, implement, and maintain warehouse QAAs and risk-based requirements.
• Partner with Procurement, Logistics, and Supplier Quality to evaluate suppliers.
• Provide quality input for warehouse supplier selection and risk-based decisions.
• Drive standardization of warehouse quality practices across sites.
• Establish risk-based monitoring and audit models with QA teams.
• Ensure alignment with QMS, SCM processes, ISO 13485 and FDA QSR.
• Monitor warehouse quality KPIs and drive improvements.
• Incoming Inspection – Service Spare Parts: Lead development of global Incoming Inspection requirements.
• Define scalable risk-based Incoming Inspection framework.
• Coordinate with multiple teams to align inspection with risk and performance.
• Establish defect classification and traceability for NCC visibility.
• Define data, KPI, and reporting requirements for visibility into inspection performance.
• Repair and Refurbishment Quality Programs: Support global quality requirements for repair/refurbishment.
• Define acceptance criteria, testing, and validation for repaired/refurbished parts.
• Drive standardization of processes across repair/refurbishment activities.
• Ensure alignment with QMS and regulatory expectations.
• Integrate outputs into CAPA, NCR, and supplier performance management.

Skills

Quality management

KPI development

Cross-functional collaboration

Data interpretation

Analytical skills

Travel readiness

Education

Bachelor’s degree in Engineering, Natural Sciences, Supply Chain, or equivalent

Tools

SAP

Excel

Power BI

Job description

Siemens Healthineers AG, in Wisconsin, seeks a Quality Programs and Warehouse Quality Oversight Lead to drive global quality frameworks for warehouse operations, service spare parts inspection, and refurbishment programs. You will collaborate with Procurement, Logistics, Supplier Quality, and Engineering to ensure regulatory compliance and scalable quality solutions.

This senior role requires 8+ years in Quality within regulated environments, strong QMS knowledge (ISO 13485, FDA QSR), and travel