Reporting to the Shipping & Receiving Manager, the Shipping & Receiving Specialist is responsible for managing the timely and accurate receipt, inspection, and shipment of materials, components, and finished products in a medical device manufacturing environment. The Shipping & Receiving Specialist ensures that inventory is properly tracked, stored, and shipped according to strict quality and regulatory requirements. The specialist will work closely with other departments, including production, quality control, and procurement, to ensure that goods are handled efficiently, safely, and in compliance with all relevant regulations. Major Responsibilities Receive incoming shipments of raw materials, components, and finished goods. Inspect shipments for accuracy, damage, and compliance with purchase orders, quality standards, and regulatory requirements (e.g., FDA, ISO 13485). Document and report discrepancies. Record and update inventory records in the Enterprise Resource Planning (ERP) system. Ensure proper stock rotation (FIFO/LIFO) and that materials are stored according to regulatory and safety guidelines. Prepare and package finished goods for shipment to customers or internal departments. Ensure shipments are correctly labeled, documented, and meet regulatory requirements for medical devices. Complete all required shipping and receiving documentation, including packing slips, bills of lading, and certificates of conformance. Ensure compliance with FDA, ISO, and other regulatory bodies' documentation requirements. Maintain accurate logs of all incoming and outgoing shipments and manage the timely transfer of materials and products between departments. Communicate with purchasing, production, and quality control teams to ensure that shipments and inventory align with production schedules, customer demands, and compliance needs. Assist in the inspection and verification of materials, including maintaining records of inspections and assisting with quarantine procedures for non-conforming products. Adhere to all safety protocols and ensure compliance with Good Manufacturing Practices (GMP), FDA regulations, ISO 13485, and other relevant standards. Operate forklifts, pallet jacks, and other equipment to move materials and finished goods safely within the warehouse or production areas. Ensure proper handling of hazardous materials or sensitive items. Manage returns, exchanges, and shipments of defective or non-conforming items. Ensure proper documentation and reconciliation of returns in the inventory system. Perform other duties as assigned. Skills and Abilities High level of attention to detail to ensure shipments and receipts are accurate and comply with medical device regulations. Strong organizational skills to manage inventory, track shipments, and maintain clear and accurate records. Ability to identify issues in the shipping/receiving process, resolve discrepancies, and handle returns and inventory issues in a timely manner. Understanding of FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP) for medical devices. Effective written and verbal communication skills to interact with internal teams, vendors, and customers. Ability to lift heavy materials (up to 50 lbs) and work on your feet for extended periods. Ability to prioritize tasks and meet deadlines in a fast-paced, dynamic environment. Proficiency in using inventory management systems (ERP systems), shipping software, and Microsoft Office (Excel, Word, Outlook). Ability to work effectively as part of a team, collaborating with logistics, quality, production, and other departments. Ability to safely operate a forklift and other warehouse equipment. High school diploma or equivalent is required. Associate's degree or vocational training in logistics, supply chain management, or a related field is preferred. 1-3 years of experience in shipping and receiving, inventory management, or warehouse operations, preferably in a regulated manufacturing or medical device environment is required. Familiarity with FDA regulations (21 CFR 820), ISO 13485, and GMP for handling medical devices and related products is required. Experience with inventory management systems (e.g., SAP, Oracle, or similar ERP systems) is required. Ability to lift up to 50 lbs. and operate warehouse equipment such as forklifts and pallet jacks is required. Strong written and verbal communication skills for documentation and coordination with various teams is required. Forklift certification, and any relevant logistics or warehouse management certifications (e.g., Certified Logistics Associate (CLA), Certified in Production and Inventory Management (CPIM), etc.) is preferred. Previous experience working in the medical device, pharmaceutical, or healthcare manufacturing industries, with knowledge of the regulatory standards is preferred. Experience with barcoding, scanning systems, or other technologies for inventory management and tracking is preferred. Familiarity with Lean or Six Sigma principles to improve shipping/receiving processes and warehouse efficiency is preferred. Ability to stand, walk, and bend for extended periods is required. Ability to work occasional overtime to meet deadlines or fulfill customer orders may be required.