Quality Engineer - Complaints and CAPA

Description: 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. LifePort 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.

Position Summary: 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. Primary Functions 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 appropriately linked to risk management, CAPA, trending, and continuous improvement processes. CAPA and Continuous Improvement Initiate, lead, or support CAPA activities arising from complaint investigations or complaint trends, Escalate complaint and CAPA-related findings requiring quality-system, process, product, supplier, labeling, servicing, or design improvements. Support continuous improvement initiatives through analysis of complaint, CAPA, nonconformance, supplier, and post-market performance data. Complaint and CAPA Review Boards and Metrics Analyze complaint investigation, service, repair, and failure-mode data to identify adverse trends, recurring issues, emerging signals, and changes in product risk profiles. Prepare Complaint and CAPA KPI metrics for Complaint Review Boards, CAPA Review Boards, Management Review, Quality System Reviews, Post-Market surveillance reviews, and audit or inspection support. Prepare materials for, schedule, convene, and lead Complaint Review Board activities, including presentation of complaint metrics, trend summaries, escalations, and follow-up actions. Schedule, convene, and support CAPA Review Board activities, including review of CAPA status, priorities, aging, effectiveness, escalations, and required cross-functional actions. Risk Management, Post-Market Support, and Quality System Support Evaluate Complaint and CAPA findings for potential impact on known hazards, hazardous situations, risk estimates, risk-control effectiveness, benefit-risk conclusions, and production or post-production information. Document and communicate investigation outputs that may require updates to risk-management files, hazard analyses, benefit-risk assessments, post-market surveillance plans, and risk-control measures. Participate in internal audits, external audits, regulatory inspections, and management-review activities as assigned.

Requirements: QUALIFICATIONS Education/Training/ Certifications/Licenses Bachelor’s degree in any technical discipline (electrical, mechanical, materials, biomedical, science, systems, or quality engineering). An equivalent combination of education, technical training, and relevant regulated-industry experience may be considered. Candidates with a master’s degree in an applicable engineering, scientific, or technical field may qualify with a minimum of two years of relevant industry experience. Minimum of four years of relevant industry experience in medical devices, complaint investigation, CAPA, quality engineering, manufacturing, supplier quality, service and repair, reliability, or post-market quality activities. Experience with at least one of the following is required. Capital equipment, sterile products, packaging, labeling, or other regulated medical device. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), CRE, Six Sigma certification, or formal root-cause analysis training is preferred. Experience Experience investigating and documenting complaints involving regulated medical-device products. Working knowledge of medical-device quality-system requirements, including Complaint handling, CAPA, Risk management, MDR/vigilance. Experience interpreting product and quality records, including specifications, drawings, bills of material, labeling, packaging information, test methods, acceptance criteria, manufacturing records, service records, complaint records, CAPA records, supplier records, and risk-management documentation. Experience applying quality-engineering and problem-solving methods, including structured root-cause analysis, fault-tree analysis, statistical analysis, measurement-system considerations, and corrective-action effectiveness verification. Experience preparing for and facilitating cross-functional meetings or review boards involving Quality, Regulatory Affairs, Engineering, Manufacturing, Service, Suppliers, Management. Experience preparing complaint metrics, CAPA metrics, trending summaries, Management Review inputs, or post-market surveillance inputs is preferred. Skills/Abilities Strong verbal and technical writing skills for clear, concise, complete, traceable, and audit-defensible complaint investigation reports, CAPA records, and quality-system records. Strong communication and cross-functional collaboration skills, including the ability to explain technical, complaint, and CAPA findings to Quality, Regulatory Affairs, Engineering, Manufacturing, Service, suppliers, auditors, and management. Ability to analyze complaint and CAPA data, detect trends, assess risk significance, prioritize, meet procedural timelines, and accelerate issues without delaying regulatory evaluation. Ability to facilitate Complaint and CAPA Review Board activities and drive timely cross-functional review, escalation, prioritization, and closure decisions within assigned authority. Proficiency with Microsoft Excel, Word, and PowerPoint; experience with statistical software, electronic QMS applications, and project-management tools is preferred. Benefits & Perks Annual incentive bonus opportunity Comprehensive medical, dental, and vision coverage Company-paid life insurance, short-term disability, and long-term disability coverage Flexible Spending Accounts (Health & Dependent Care FSA) 401(k) with 100% company match on the first 5% of employee contributions Company-paid life insurance and disability coverage Generous paid time off, including vacation, sick, personal, volunteer time, and paid holidays Paid parental leave Summer hours program Tuition reimbursement and professional development support Employee Assistance Program (EAP) and identity theft protection Pet insurance and legal plan options Technology and wellness reimbursement STEM scholarship program Be ATicated?

Why Join Us? At Organ Recovery Systems, we invest in our people by providing competitive benefits that support your health, financial well-being, career growth, and life outside of work. Annual Incentive Bonus Opportunity Comprehensive Medical, Dental & Vision Coverage Company-Paid Life Insurance, Short-Term & Long-Term Disability Coverage Flexible Spending Accounts (Health & Dependent Care FSA) 401(k) with 100% Company Match on the First 5% of Contributions Generous Paid Time Off, Including Vacation, Sick, Personal, Volunteer Time & Paid Holidays Paid Parental Leave Summer Hours Program Tuition Reimbursement & Professional Development Support Employee Assistance Program (EAP) & Identity Theft Protection Pet Insurance & Legal Plan Options Technology & Wellness Reimbursement STEM Scholarship Program for Eligible Dependents A Culture Focused on Employee Well-Being, Growth, and Work-Life Balance