Operations Manager (Medical Device Logistics)

[Job Description]

Key Responsibilities

• Oversee daily operations including inventory control, shipping/receiving, and order fulfillment within a regulated medical device environment
• Ensure inventory accuracy and traceability, including lot, serial, and UDI compliance across all transactions
• Manage inventory planning and stock levels, including safety stock, purchase orders, and consignment inventory support to meet surgical demand
• Lead warehouse operations, ensuring efficient processes and compliance with QMS, FDA (21 CFR Part 820), and internal procedures
• Coordinate cross-functionally with Sales, Customer Service, Quality, and external partners to ensure timely product availability and issue resolution
• Monitor and improve operational performance through KPIs (e.g., inventory accuracy, service levels, stockouts) and process improvements
• Supervise and develop team members, including scheduling, training, and performance management
• Support regulatory and quality requirements, including audits, CAPAs, returns (RMA), and recall readiness
• Provide reporting and analytics on inventory, logistics, and operational performance to management
• Support field operations, including inventory audits, loaner set management, and on-call coverage for inventory-related issues

Qualifications

• 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 and ISO requirements

Technical Skills

• Advanced proficiency in Microsoft Excel (pivot tables, lookups, data analysis)
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint)
• Experience with inventory management platforms
• 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

1. 100% health Insurance
2. 401k 5%
3. PTO