Operations Manager - Medical Device

Location: Laguna Hills, CA Salary: $115,000 - $120,000 Bonus: 10% Position Summary The Operations Manager is responsible for overseeing logistics, inventory management, and warehouse operations to ensure high service levels, regulatory compliance, and inventory accuracy. This role is critical to maintaining compliant product traceability (UDI, lot/serial control), supporting consignment inventory models, and ensuring timely product availability for surgical cases. The Operations Manager partners cross-functionally with Sales, Customer Service, Quality/Regulatory, and external partners to support operational excellence and continuous improvement. Key Responsibilities Logistics & Inventory Management Manage daily logistical operations including inventory control, shipping/receiving, and order fulfillment in a regulated medical device environment. Maintain accurate inventory records including lot, serial, and UDI traceability across all transactions. Monitor inventory levels and perform cycle counts, audits, and reconciliations to ensure compliance and accuracy. Execute inventory planning activities including order calculations, purchase order creation, and safety stock management aligned with service level targets. Support consignment inventory strategies, ensuring adequate field inventory to meet surgical demand while minimizing excess and obsolescence. Warehouse Operations & Compliance Oversee warehouse organization, transaction accuracy, and material handling in accordance with FDA QSR (21 CFR Part 820) and internal Quality Management System (QMS) requirements. Ensure proper handling of returned goods (RMA), expired products, and nonconforming inventory in compliance with company procedures. Maintain inspection, receiving, and documentation processes to support product quality and regulatory compliance. Support internal and external audits by maintaining accurate records and documentation. Traceability & Regulatory Support Ensure full compliance with UDI requirements, including consistency across shipping documentation, labeling, and system records. Maintain end-to-end traceability of products from receipt through distribution and return. Partner with Quality/Regulatory teams on CAPAs, audits, and investigations related to inventory discrepancies, complaints, or field actions. Support recall readiness by ensuring accurate and accessible inventory and distribution data. Cross-Functional Coordination Coordinate with Sales, Customer Service, and Logistics teams to ensure timely delivery of implants and instruments for surgical cases. Communicate with customers and distributors regarding order status, product availability, returns, and inventory issues. Liaise with suppliers, freight carriers, and internal departments to resolve operational challenges and ensure continuity. Performance & Process Improvement Monitor and report on key operational KPIs (e.g., inventory accuracy, service level, stockouts, backorders). Identify inefficiencies and implement process improvements to enhance productivity, accuracy, and scalability. Support initiatives to optimize inventory utilization, including management of slow-moving and expiring products. Reporting & Analytics Prepare and present reports on inventory levels, logistics performance, and operational metrics to management. Analyze usage trends, demand patterns, and field inventory levels to support forecasting and decision-making. Team Leadership Supervise warehouse and logistics personnel including scheduling, coverage, and payroll tracking. Provide training on SOPs, regulatory requirements, and system processes. Enforce compliance with company policies, procedures, and safety standards. Operational Support & Field Activities Participate in a rotating on-call schedule, including weekend and holiday coverage for inventory-related issues. Conduct field inventory audits and reconciliations at distributor and hospital locations (travel required). Support key operational activities such as loaner set/bin management, case support readiness, and inventory troubleshooting. Additional Responsibilities Implement, maintain, and enforce standard operating procedures (SOPs). Perform additional duties as assigned in alignment with company objectives. Qualifications Education & Experience Bachelor's degree in Supply Chain, Operations, Business, or related field (preferred). 5+ years of experience in operations, logistics, or inventory management within the medical device or regulated healthcare industry. Experience supporting consignment inventory models and surgical case support strongly preferred. Working knowledge of FDA QSR (21 CFR Part 820) and/or ISO 13485 requirements. Technical Skills Advanced proficiency in Microsoft Excel (pivot tables, lookups, data analysis). Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint). Experience with ERP systems (e.g., NetSuite, SAP, Oracle, or equivalent). Experience with inventory management platforms (e.g., ImplantBase or similar systems). Familiarity with UDI requirements and traceability systems. Experience with reporting/BI tools (Power BI or similar) is a plus. Core Competencies Strong understanding of inventory control, lot traceability, and regulated distribution practices. High attention to detail with a focus on accuracy and compliance. Analytical mindset with the ability to interpret operational data and drive decisions. Strong problem-solving and process improvement capabilities. Ability to manage competing priorities in a fast-paced, case-driven environment. Effective communication and cross-functional collaboration skills. Proven leadership and team management experience. Other Requirements Ability to travel for field inventory audits and customer support as needed. Willingness to participate in an on-call rotation for operational support. #J-18808-Ljbffr Integress Inc