Quality Engineer - Medical Devices: Investigation & CAPA

Organ Recovery Systems; Itasca (IL); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Annual incentive bonus opportunity

Comprehensive medical, dental, and vis

401(k) with company match

Paid time off and holidays

Tuition reimbursement and development

Job summary

Organ Recovery Systems in Itasca, IL seeks a Quality Engineer – Device Investigation to coordinate and document investigations of medical devices, including hardware, software, and disposables. You will apply risk-based methods, maintain audit-ready records, and support QMS compliance across regulatory requirements.

You will work cross-functionally with Quality, Regulatory Affairs, Engineering, Manufacturing and Suppliers to link investigations to CAPA, risk management, and post-market

Qualifications

• Bachelor’s degree in a technical discipline and 4+ years in medical-device quality.
• Master’s degree may qualify with additional relevant experience.
• Experience with CAPA, complaint investigation, MDR/vigilance, and risk management.

Responsibilities

• Coordinate and document device investigations and CAPA activities.
• Ensure complaint records are complete, traceable, and defensible.
• Support risk-management updates and post-market surveillance.
• Lead cross-functional review boards and communicate findings clearly.

Skills

Quality engineering

Regulatory knowledge

Root-cause analysis

Cross-functional work

CAPA

Education

Bachelor’s degree in electrical, mechanical, biomedical, or related field

Master’s degree in applicable engineering/science field (preferred)

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Statistical software

Electronic QMS systems

Job description

Organ Recovery Systems in Itasca, IL seeks a Quality Engineer – Device Investigation to coordinate and document investigations of medical devices, including hardware, software, and disposables. You will apply risk-based methods, maintain audit-ready records, and support QMS compliance across regulatory requirements.

You will work cross-functionally with Quality, Regulatory Affairs, Engineering, Manufacturing and Suppliers to link investigations to CAPA, risk management, and post-market