PSI Operations Coordinator

What You Can Expect

Paragon 28 (Zimmer Biomet) is hiring a PSI Operations Coordinator to join our team in Englewood Colorado. This is an onsite role. Operations Coordinator to play a key role in our patient specific manufacturing, product packaging, and distribution operations. The ideal candidate will possess strong operational acumen, attention to detail, and a proactive approach to driving efficiency and maintaining quality. You will serve as a critical liaison between cross-functional teams, ensuring timely and accurate execution of case submission, manufacturing, product packaging, labeling, shipping, and order processing.

How You'll Create Impact

• Labeling and Compliance: Oversee the generation, printing, and verification of product labels to ensure compliance with internal standards and regulatory requirements (e.g., FDA, ISO).
• Quality Assurance: Review final products to confirm packaging integrity, accurate labeling, correct quantities, and overall compliance with quality specifications. Ensure all associated documentation is complete and accurate before shipping.
• Shipping and Distribution: Coordinate the timely packaging and shipping of finished goods, ensuring products are dispatched according to established schedules and in line with customer requirements.
• Cross-Departmental Coordination: Maintain proactive communication with the Quality Inspection Lab, Materials Management, and Production teams to address operational needs, resolve any discrepancies, and drive continuous improvement.
• Order Processing: Efficiently process and manage incoming purchase orders, ensuring the accurate entry of data into the SAP system and verifying alignment with engineering specifications and inventory needs.
• Vendor Relationship Management: Establish and maintain effective communication with vendors to monitor and expedite product procurement, resolve inquiries, and ensure timely delivery of materials.
• Operational Excellence: Monitor operational workflows and identify opportunities for process improvements to streamline packaging, labeling, and shipping activities. Contribute to the development and refinement of standard operating procedures (SOPs) to ensure best practices and regulatory compliance.
• Documentation and Reporting: Ensure accurate and thorough documentation of all activities, including purchase orders, inventory updates, and shipping logs, to support compliance audits and internal tracking requirements.
• System Management: Utilize SAP and other relevant software tools to update and track purchase orders, pricing, and inventory levels. Provide support for system troubleshooting and data entry as needed.

What Makes You Stand Out

• Educational Background: Associate's degree preferred, or equivalent experience required. A background in supply chain management, logistics, or related fields is preferred.
• Experience: A minimum of 2 years of experience in operations coordination, logistics, or a similar role, preferably within a regulated industry such as medical devices, pharmaceuticals, or manufacturing.
• Technical Skills: Proficiency with MS Office Suite (Word, Excel, Outlook, Teams). Knowledge of SAP or similar ERP systems is highly preferred.
• Attention to Detail: Exceptional organizational skills and an acute attention to detail, with a strong commitment to ensuring operational accuracy and product quality.
• Problem-Solving: Strong analytical skills with the ability to proactively identify issues, troubleshoot challenges, and implement effective solutions.
• Communication Skills: Excellent verbal and written communication skills with the ability to interact effectively with internal teams, vendors, and regulatory bodies.
• Time Management: Proven ability to manage multiple priorities in a fast-paced, deadline-driven environment while maintaining accuracy and quality standards.
• Regulatory Knowledge: Familiarity with FDA regulations, ISO standards, and other compliance requirements in the medical device industry is a plus.

Travel Expectations

No travel required.