Quality Programs and Warehouse Quality Oversight Lead
About the role
Sustainably, we are pioneering breakthroughs in healthcare for everyone everywhere. Join a global community of over 72,000 highly dedicated professionals from diverse backgrounds, united by a shared purpose: to fight the world's most threatening diseases and enable access to care.
Responsibilities
Lead the development, maintenance, and deployment of global Warehouse Requirements documents, ensuring clarity, scalability, and alignment with regulatory and business needs.
Define, implement, and maintain warehouse-specific Quality Assurance Agreements (QAAs), including alignment with supplier types and risk-based requirements.
Partner with Procurement, Logistics, and Supplier Quality to support warehouse supplier selection, evaluation, qualification, and ongoing monitoring.
Provide quality input and guidance during warehouse supply base selection to enable risk-based decision making.
Drive standardization of warehouse quality practices across sites, including receiving, storage, handling, segregation, returns, refurbishment, and dispatch.
Establish risk-based monitoring and oversight models, leveraging Supplier Quality and Service Quality teams for audits and surveillance.
Ensure alignment of warehouse practices with QMS, SCM processes, and regulatory requirements (ISO 13485, FDA QSR).
Monitor and analyze warehouse quality KPIs to identify trends and drive systemic improvements.
Lead development and standardization of global Incoming Inspection requirements for Service Spare Parts, including inspection criteria, sampling strategies, and acceptance standards.
Partner with Supplier Quality, Customer Service, Engineering, and Operations to align inspection requirements with product risk, supplier performance, and regulatory expectations.
Define clear classification and traceability of defects to enable identification of supplier-related issues and support NCC visibility.
Define data, KPI, and reporting requirements to provide visibility into Incoming Inspection effectiveness, defect trends, and supplier quality performance.
Support development and implementation of global quality requirements for Repair and Refurbishment programs related to Service Spare Parts.
Partner with Customer Service, Engineering, Operations, and Supplier Quality to define acceptance criteria, testing requirements, and validation expectations for repaired and refurbished parts.
Drive standardization of processes including traceability, documentation, inspection, and release criteria across repair/refurbishment activities.
Ensure alignment of Repair and Refurbishment activities with QMS requirements, regulatory expectations, and product performance standards.
Integrate Repair and Refurbishment outputs into broader quality systems including CAPA, NCR, and supplier performance management processes.
Requirements
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.
Strong analytical skills including KPI development, trend analysis, and data interpretation.
Proficiency with SAP, Excel, and data visualization tools (e.g., Power BI).
Strong communication skills with the ability to translate requirements into actionable guidance.
Willingness to travel (~15–20%).