Quality Specialist

Quality Specialist

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.

The Quality Specialist is responsible for supporting and maintaining the effectiveness of the Quality Management System (QMS) in accordance with FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, MDSAP requirements, and other applicable regulatory requirements. The Quality Specialist supports product quality assurance activities including product review and release, complaint handling, internal audits, document control, corrective action processes, and continuous monitoring of QMS effectiveness.

Primary (Essential) Functions :

1. Product Review and Release

• Review Device History Records (DHRs), manufacturing records, test results, and associated quality records to verify product acceptance criteria have been met prior to release.
• Perform quality review and disposition of product lots in accordance with approved procedures and release requirements.
• Verify completion of required manufacturing, inspection, testing, and labeling activities prior to release.
• Escalate identified quality issues, deviations, or nonconformances that may impact product release.
• Support investigation and resolution of release-related quality issues.

2. Complaint Handling and Investigation

• Review, document, and process customer complaints in accordance with complaint handling procedures.
• Evaluate complaints for completeness, investigation requirements, risk significance, and potential regulatory reporting obligations.
• Support complaint investigations to determine root cause and identify corrective actions where appropriate.
• Perform complaint trending and analysis to identify recurring issues and emerging quality signals.
• Escalate potentially reportable events and significant quality issues to Quality and Regulatory leadership.
• Maintain complaint records in compliance with applicable regulatory requirements.

3. Internal and Supplier Audits

• Conduct audits in accordance with established audit schedules and approved audit procedures.
• Assess QMS processes for conformity to internal procedures, FDA QMSR, ISO 13485, ISO 14971, and other applicable requirements.
• Document audit findings and opportunities for improvement.
• Verify implementation and effectiveness of corrective actions arising from audits.
• Support audit readiness activities and external inspections.

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 one year of relevant industry experience.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), CRE, Six Sigma certification, or formal root-cause analysis training is preferred.

Experience:

• Two or more years of relevant regulated-industry experience.
• Working knowledge of FDA QMSR, ISO 13485, ISO 14971, MDSAP, complaint handling, product acceptance and release, CAPA, internal auditing, document control, and record control requirements.
• Experience reviewing manufacturing and test records and conducting or supporting quality investigations is preferred.

Skills/Abilities :

• Strong communication skills with the ability to address all levels within the organization
• Strong computer skills (Excel, Word, PowerPoint)
• Flexible; able to multi-task different projects and priorities.
• Ability to interact effectively to accomplish objectives with multiple departments.

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
• 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

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.