Senior Manager, Service Supply Chain Quality
About the role
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%.
The base pay range for this position is:
$167,030 - $229,669
Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
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