The Customer Communications Coordinator is responsible for maintaining accurate customer communication records, managing inquiry documentation and investigation documentation in accordance with the Company's Quality Management System (QMS), and ensuring the accurate entry and processing of customer orders received outside of the Company's e-commerce platform.

This position serves as a primary administrative liaison between customers, quality personnel, sales personnel, and management to ensure that customer inquiries, complaints, service requests, purchase orders, and fulfillment records are properly documented, tracked, and maintained. The role is critical to maintaining regulatory compliance, customer satisfaction, and data integrity across all Emergent Respiratory operations.

Customer Complaint and Communication Management

• Receive, document, and maintain records of customer complaints, product concerns, adverse event reports, service concerns, and other quality-related communications.

• Ensure complaint files are established, maintained, and archived in accordance with applicable procedures and record retention requirements.

• Gather and organize supporting documentation including emails, letters, photographs, service records, returned product information, and customer statements.

• Coordinate with Quality Assurance, Regulatory Affairs, Operations, and Management personnel during complaint investigations.

• Monitor complaint status and assist in ensuring timely follow-up and closure activities.

• Maintain complaint logs, tracking systems, and related quality records.

• Escalate potentially reportable events, safety concerns, or significant product issues to management immediately.

• Assist in preparation of complaint metrics, trend reports, and management review materials.

Customer Communications Administration

• Maintain complete and accurate records of customer communications related to orders, service activities, complaints, technical inquiries, and account matters.

• Ensure customer communications are documented and filed in the appropriate systems.

• Coordinate communication between customers and internal departments when necessary.

• Assist in responding to customer inquiries regarding products, services, orders, warranties, certifications, and service programs.

• Maintain professionalism and consistency in customer interactions.

Order Entry and Purchase Order Processing

• Receive and process customer purchase orders submitted by email, telephone, written correspondence, verbal communication, or other non-website channels.

• Enter customer orders accurately into the Company's order management systems.

• Verify product descriptions, quantities, pricing, shipping information, and customer account information prior to order release.

• Coordinate with customers to resolve discrepancies or incomplete information.

• Maintain documentation supporting all manually entered orders.

• Assist with order tracking, status updates, and fulfillment coordination.

Fulfillment and Record Management

• Maintain accurate records of all product fulfillments, shipments, exchanges, service transactions, and related customer activities.

• Verify that fulfillment records are complete and properly associated with the applicable customer, order, and product records.

• Assist in maintaining traceability records for regulated medical devices.

• Support inventory, service, and quality record reconciliation activities.

• Ensure all required documentation is retained in accordance with Company procedures and regulatory requirements.

Quality System Responsibilities

• Comply with all Company Quality Management System procedures.

• Follow applicable complaint handling, document control, record retention, corrective action, and regulatory procedures.

• Participate in internal audits, inspections, and continuous improvement activities as assigned.

• Maintain confidentiality of customer, company, and regulatory information.

• Support regulatory compliance efforts related to medical device operations.

Required

• High school diploma or equivalent required; associate or bachelor's degree preferred.

• Strong organizational and documentation skills.

• Excellent written and verbal communication skills.

• Proficiency with Microsoft Office applications and business software systems.

• Ability to manage multiple priorities while maintaining attention to detail.

• Ability to handle confidential and sensitive information appropriately.

Preferred Qualifications

• Experience working within a regulated medical device environment.

• Familiarity with complaint handling procedures and quality management systems.

• Experience with ERP, CRM, e-commerce, or order management software.

• Experience maintaining controlled records and documentation.

• Experience operating in accordance with documented procedures, quality standards, or regulatory requirements.

• Experience working within an ISO 13485 and/or ISO 9001 certified quality management system.