We are seeking a hands-on, detail-oriented Fulfillment Manager to lead inventory and logistics operations in a regulated environment. This role is pivotal in ensuring accurate inventory control, efficient order fulfillment, and compliance with ISO 13485:2016 and CE Mark standards. The ideal candidate will bring experience in regulated industries, ERP systems, and team leadership, with a proactive mindset for process improvement.
• Lead cycle counting and reconciliation processes; identify discrepancies and drive improvements
• Ensure traceability through serial/lot number control in compliance with ISO 13485:2016 and CE Mark
• Collaborate with Senior Director of Operations on forecasting and inventory optimization
• Manage pick, pack, and ship processes to meet KPIs and SOP standards
• Coordinate domestic and international shipments, ensuring regulatory documentation is complete
• Identify and implement fulfillment process enhancements
🖥 ERP Transition & System Development
• Support ERP system selection, implementation, and training
• Collaborate cross-functionally to map workflows and migrate data from QuickBooks
• Drive continuous improvement in ERP utilization and reporting
📑 Compliance & Documentation
• Ensure fulfillment and inventory practices align with ISO 13485:2016, FDA, MDR, and other standards
• Maintain detailed records of inventory movements, traceability, and shipping documentation
• Participate in audits and contribute to CAPA investigations
👥 Team Leadership
• Supervise inventory and fulfillment staff; provide training, direction, and performance feedback
• Foster a culture of safety, quality, and accountability
🧠 Required Experience & Skills
• 5+ years in inventory, logistics, or fulfillment—preferably in medical device or regulated industries
• Experience with QuickBooks inventory/ful
fillment; ERP implementation or usage
• Familiarity with domestic/international shipping software and documentation
• 2+ years of team leadership experience
• Strong communication, organizational, and analytical skills
• Ability to lift up to 50 lbs and work on feet for extended periods
• Forklift experience (certification provided)
🌟 Preferred Qualifications
• Understanding of ISO 13485:2016 and quality system requirements
• Experience managing fulfillment in a medical device company
🎓 Education
• Bachelor’s degree in Supply Chain, Business, Operations, or related field
💼 Compensation & Benefits
• Competitive salary based on experience
• Performance-based bonus
• Comprehensive benefits package including health, dental, and 401(k)
• Paid time off and holidays
• Professional development opportunities