Our client is a leading medical device manufacturer dedicated to the design, development, and production of innovative devices and therapies that treat a wide range of health conditions. Operating in compliance with ISO 13485, FDA 21 CFR Part 11, and cGMP regulations, the company has built a reputation for quality, reliability, and patient-focused innovation. As part of their growing operations team, they are seeking an experienced Shipping and Receiving Clerk to ensure the accurate, efficient, and compliant handling of all inbound and outbound materials, components, and finished medical devices.
Typical Duties and Responsibilities
- Manage shipping and receiving operations in accordance with FDA QSR (Quality System Regulations), ISO 13485, and Good Manufacturing Practices (GMP).
- Receive, inspect, and verify incoming materials, raw components, and medical device parts against purchase orders, packing slips, and bills of lading.
- Prepare and package outbound shipments, ensuring compliance with domestic and international shipping regulations (FedEx, UPS, DHL, LTL/Freight).
- Maintain accurate records in ERP/MRP systems such as SAP, Oracle NetSuite, JD Edwards, or Microsoft Dynamics.
- Create shipping documentation, including packing lists, certificates of conformance, and customs declarations.
- Perform inventory transactions including material receipts, transfers, and adjustments in accordance with company policies.
- Ensure compliance with ESD (Electrostatic Discharge) handling procedures when moving sensitive electronic components.
- Operate warehouse equipment including forklifts, pallet jacks, and automated material handling systems.
- Collaborate with Quality Assurance (QA) to manage nonconforming material returns (RMA) and ensure proper labeling, segregation, and documentation.
- Support cycle counts, physical inventory audits, and lean manufacturing initiatives to improve warehouse efficiency.
- Communicate with purchasing, production, and customer service teams to ensure on-time delivery and efficient material flow.
Education
- High school diploma or GED required.
- Associate’s degree in Business, Supply Chain, Logistics, or related field preferred.
Required Skills and Experience
- 2+ years of experience in shipping and receiving, warehouse operations, or logistics, ideally in the medical device, pharmaceutical, or regulated manufacturing industry.
- Familiarity with ISO 13485, FDA QSR, and GMP compliance requirements.
- Proficiency in ERP/MRP systems (SAP, Oracle NetSuite, JD Edwards, Epicor, Microsoft Dynamics, or similar).
- Strong computer skills, including Microsoft Excel, Word, and Outlook.
- Ability to read and interpret packing slips, bills of lading, purchase orders, and work instructions.
- Knowledge of domestic and international shipping regulations.
- Strong organizational skills, attention to detail, and ability to work in a fast-paced environment.
- Forklift certification or ability to obtain one.
- Excellent communication skills with the ability to work cross-functionally across departments.
Preferred Qualifications
- Experience working in medical device, biotech, or pharmaceutical industries.
- Knowledge of LEAN, Six Sigma, 5S, and continuous improvement methodologies.
- Familiarity with cold chain packaging, sterile packaging, or hazardous materials (HAZMAT) shipping requirements.
- Experience with barcode scanning systems and warehouse automation tools.
- Previous involvement with RMA processing, CAPA (Corrective and Preventive Actions), or quality-related investigations.
- Certifications such as APICS CPIM (Certified in Production and Inventory Management), CLTD (Certified in Logistics, Transportation, and Distribution), or OSHA forklift certification are a plus.
