Inventory & Traceability Specialist - Medical Products

Spine Craft develops, manufactures and distribute spine surgery implant & instrument systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.

We are looking for an Inventory & Traceability Specialist to join our team in Westmont, IL.

The Inventory & Traceability Specialist is responsible for maintaining accurate inventory records and ensuring full traceability of regulated components and finished goods in a clean, non-warehouse environment. This role relies heavily on ERP and PLM systems to track lot numbers, serial numbers, expiration dates, and chain-of-custody documentation. The role also involves organizing physical inventory, dispatching materials per controlled templates, performing regular reconciliations, supporting audits, and ensuring compliance with GMP, ISO 13485, and applicable regulatory requirements.

• Maintain accurate inventory transactions and traceability records in ERP and PLM systems.
• Organize and maintain physical inventory in designated storage clean areas.
• Dispatch inventory according to predefined templates and controlled documents.
• Organize, label, and store inventory in designated clean drawers or controlled storage areas.
• Ensure traceability and proper documentation of product movements, including lot/batch tracking.
• Conduct regular cycle counts, investigate discrepancies, support inventory audits or inspections, and implement corrective actions where needed.
• Maintain clean, orderly, and audit-ready inventory areas.
• Perform regular inventory reconciliations and discrepancy investigations.
• Coordinate with Purchasing, Supply chain, and Quality teams to ensure timely availability and release of products.
• Prepare inventory documentation for internal audits and external inspections (e.g., FDA, ISO).
• Assist in quarantines, disposition of non-conforming products, and recalls.
• Ensure all activities are performed in accordance with GMP, and internal SOPs.

• At least 3 years’ experience in a regulated environment (medical device, pharmaceutical, biotech, etc.).
• Associate degree is required at a minimum;
  Bachelor's degree is preferred.
• Proficiency in inventory management and/or PLM systems.
• Strong attention to detail and familiarity with batch/lot traceability.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, and UDI is preferred.
• Excellent organizational and communication skills.