Quality Assurance Specialist – Medical Devices & Compliance

Organ Recovery Systems; Itasca (IL); On-site; USD 65,000 - 95,000; Full time

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

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