Senior Manager, Service Supply Chain Quality

Warehouse Quality Oversight

• Lead the development, implementation, and maintenance of global warehouse quality requirements, ensuring alignment with business needs, the Quality Management System, and applicable regulatory requirements.
• Develop and maintain warehouse-specific Quality Assurance Agreements (QAAs), applying risk-based requirements based on supplier type, scope, and criticality.
• Partner with Procurement, Logistics, Supplier Quality, and other stakeholders to support warehouse and 3PL supplier selection, qualification, ongoing monitoring, and performance management.
• Provide quality expertise during warehouse supplier selection and change activities to enable effective, risk-based decisions.
• Drive consistent warehouse quality practices across internal and external sites, including receiving, storage, handling, segregation, returns, refurbishment, and dispatch.
• Establish risk-based oversight and monitoring models, leveraging Supplier Quality and Service Quality resources for audits, assessments, and surveillance activities.
• Ensure warehouse operations align with QMS, Supply Chain Management processes, and applicable regulatory requirements, including ISO 13485 and FDA Quality System requirements.
• Establish and monitor warehouse quality KPIs, analyze trends and risks, and drive systemic improvements across the warehouse network.

Incoming Inspection: Service Spare Parts

• Lead the development and standardization of global Incoming Inspection requirements for Service Spare Parts, including inspection criteria, sampling strategies, and acceptance standards.
• Develop a scalable, risk-based Incoming Inspection framework for internal sites and external warehouse/3PL partners.
• Partner with Supplier Quality, Customer Service, Engineering, and Operations to align inspection requirements with product risk, supplier performance, and quality requirements.
• Establish consistent defect classification, documentation, and traceability to improve visibility into supplier-related issues and nonconformance trends.
• Define KPIs, data requirements, and reporting processes to measure Incoming Inspection effectiveness, identify defect trends, and improve supplier quality performance.

Repair and Refurbishment Quality Programs

• Lead the development and implementation of global quality requirements for Service Spare Parts repair and refurbishment programs.
• Partner with Customer Service, Engineering, Operations, and Supplier Quality to establish acceptance criteria, testing requirements, and validation expectations for repaired and refurbished parts.
• Standardize requirements for traceability, documentation, inspection, testing, and release across repair and refurbishment activities.
• Ensure repair and refurbishment processes align with QMS requirements, applicable regulatory expectations, and product performance standards.
• Integrate repair and refurbishment quality results into broader quality processes, including CAPA, NCR/nonconformance management, and supplier performance management.
• Analyze repair and refurbishment quality trends to identify systemic issues and opportunities to improve part reliability, supplier performance, and service outcomes.

What You Will Have

• Bachelor's degree in Engineering, Natural Sciences, Supply Chain, or a related discipline, or equivalent relevant experience. An advanced degree is preferred.
• 8+ years of progressive experience in Quality within a regulated or quality-critical industry; medical device experience is strongly preferred.
• Experience working with warehouse, distribution, logistics, or third-party logistics (3PL) operations, including developing or implementing quality requirements and Quality Assurance Agreements.
• Experience with supplier quality management, including supplier selection, qualification, monitoring, audits, and performance management.
• Experience developing or managing Incoming Inspection processes, preferably in a service parts, manufacturing, distribution, or regulated environment.
• Knowledge of repair, refurbishment, returns, or service-parts quality processes is preferred.
• Strong understanding of Quality Management Systems and applicable regulatory requirements, including ISO 13485 and FDA requirements.
• Demonstrated ability to develop standardized, scalable quality processes across multiple locations, suppliers, or regions.
• Strong analytical capabilities, including KPI development, trend analysis, risk assessment, and data-driven problem solving.
• Experience working cross-functionally and influencing stakeholders without direct authority.
• Strong written and verbal communication skills, with the ability to translate complex quality and regulatory requirements into clear, actionable guidance.
• Proficiency with SAP, Excel, and data analytics or visualization tools such as Power BI.
• Willingness to travel approximately 15-20%.