Quality Engineer - Complaints and CAPA

About the company

Headquartered in Itasca, Illinois, with a satellite location in Belgium, Organ Recovery Systems is a global market-leading provider of organ preservation products and services. We support over 400 transplant programs across 49 countries. In 2025, the company reached 275,000 kidneys perfused with LKT since its launch in 2003. Life Port Kidney Transporter is among a growing family of products and services developed by Organ Recovery Systems to support the Company’s mission of honoring organ donation by delivering innovative solutions that support transplant professionals and improve long-term outcomes for patients.

Headquartered in Itasca, Illinois, with a satellite location in Belgium, Organ Recovery Systems is a global market-leading provider of organ preservation products and services. We support over 400 transplant programs across 49 countries. In 2025, the company reached 275,000 kidneys perfused with LKT since its launch in 2003. Life Port Kidney Transporter is among a growing family of products and services developed by Organ Recovery Systems to support the Company’s mission of honoring organ donation by delivering innovative solutions that support transplant professionals and improve long-term outcomes for patients.

The Quality Engineer – Device Investigation is responsible for coordinating and documenting technically sound, timely, and audit-defensible investigations of returned and field-reported medical devices, including electromechanical equipment, software or firmware-enabled products, disposable components, and preservation solutions. The position applies approved investigation methods, risk-based decision-making, and objective evidence to determine failure mechanisms and, when reasonably achievable, root cause.

The position also supports the effectiveness of the Quality Management System (QMS) and related Quality Engineering activities in accordance with applicable procedures and regulatory requirements, including the FDA Quality Management System Regulation (QMSR), ISO 13485, the Medical Device Single Audit Program (MDSAP), Regulation (EU) 2017/745 (EU MDR), ISO 14971, and other applicable market requirements. The role works cross-functionally with Quality, Regulatory Affairs, Engineering, Manufacturing, Service, Operations, contract manufacturers, and suppliers to ensure investigation outputs are appropriately linked to complaint handling, regulatory evaluation, risk management, CAPA, post-market surveillance, design and process improvement, and quality-system records.

• Device and Complaint Investigation
• Perform complaint-handling activities for capital equipment, disposable products, serviced devices, field reports, and verbal complaints in accordance with approved procedures and regulatory requirements.
• Triage complaints with Helpline specialists, Engineering, Manufacturing, and cross-functional stakeholders to determine investigation scope, risk priority, escalation needs, and supplier involvement.
• Escalate safety concerns, significant quality issues, and investigation limitations to designated Quality, Regulatory, Engineering, or management stakeholders in accordance with procedural requirements and timelines.
• Support timely regulatory assessment of potentially reportable events by ensuring complaint records include the technical information, investigation status, and rationale needed for Quality and Regulatory decision-making.
• Maintain complete, accurate, traceable, and audit-defensible complaint records, including investigation results, conclusions, coding, classification, rationale, corrective actions, and complainant responses when applicable.
• Support complaint closure and ensure complaint outcomes are…