Shipping & Receiving Specialist

About the role

The Shipping & Receiving Specialist plays a critical role in ensuring the timely and accurate receipt, inspection, and shipment of materials, components, and finished products in a medical device manufacturing environment. This position requires a high level of attention to detail, strong organizational skills, and familiarity with FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP).

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.
• Absorb and 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.

Requirements

• High school diploma or equivalent is required.
• An 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.