Quality Specialist

Organ Recovery Systems

Itasca (IL)

On-site

USD 65,000 - 95,000

Full time

3 days ago

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Benefits offered by this job

Annual incentive bonus

Comprehensive medical, dental, and vis

401(k) with company match

Paid time off

Paid parental leave

Summer hours program

Tuition reimbursement

Professional development support

EAP & identity protection

Technology & wellness reimbursement

Job summary

Organ Recovery Systems, headquartered in Itasca, IL, is a global leader in organ preservation solutions. The Quality Specialist will support the Quality Management System (QMS) to ensure regulatory compliance under FDA QMSR, ISO 13485, ISO 14971, and MDSAP, while supporting product release, complaint handling, internal audits, and CAPA processes.

The role emphasizes maintaining document control, continuous monitoring of QMS effectiveness, and collaboration with multiple departments to uphold

Qualifications

Two or more years of regulated-industry experience.
Knowledge of FDA QMSR, ISO 13485, ISO 14971, MDSAP, and complaint handling.
Experience reviewing manufacturing and test records and conducting quality investigations is preferred.
CQE/CQA/CRE or Six Sigma certification or formal root-cause analysis training is preferred.

Responsibilities

Review DHRs, manufacturing records, test results and associated quality records before release.
Perform quality review and disposition of product lots per procedures and release requirements.
Support investigation and resolution of release-related quality issues.
Conduct audits and support internal and supplier audits to ensure QMS conformance.

Skills

Communication skills

Computer skills

Multi-tasking

Cross-functional collaboration

Education

Bachelor's degree in a technical discipline

Master's degree in engineering/science (optional)

CQE/CQA/CRE or Six Sigma training preferred

Job description

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. 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.

Description

Position Summary

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

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.
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.
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

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
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

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