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