Operations Manager (Medical Device Logistics)

Cesna RecruitmentLaguna Hills, CA

About The Position

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

Requirements

  • 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
  • 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
  • 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
  • Ability to travel for field inventory audits and customer support as needed
  • Willingness to participate in an on-call rotation for operational support

Nice To Haves

  • Experience with reporting/BI tools (Power BI or similar) is a plus

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

Benefits

  • 100% health Insurance
  • 401k 5%
  • PTO
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