Quality Operations Director – Medical Devices (3 Platforms)

The Mullings Group; Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

Organ Recovery Systems in Itasca, IL, is seeking a Director of Quality Operations to own manufacturing quality, product release, and field quality. You will oversee three technology platforms: capital equipment, perfusate solutions, and EO sterilized disposables, ensuring inspection readiness and on-time delivery.

The role collaborates with Manufacturing, Supply Chain, and Engineering, reporting to the SVP of Quality and Regulatory.

Qualifications

• 10+ years in medical device quality operations
• 5+ years leading quality teams in regulated manufacturing
• Experience managing quality through contract manufacturers and suppliers
• Strong command of FDA QMSR, ISO 13485 and EU MDR

Responsibilities

• Own manufacturing quality and product release
• Lead quality oversight across US contract manufacturers
• Drive CAPA and nonconformance resolution
• Own field quality and complaint investigations
• Collaborate with Manufacturing, Supply Chain and Engineering

Skills

Quality ops leadership

Contract manufacturers

Regulatory knowledge (FDA QMSR)

ISO 13485

EU MDR

CAPA & NCR

Cross-functional collab

Supplier quality

Job description

Organ Recovery Systems in Itasca, IL, is seeking a Director of Quality Operations to own manufacturing quality, product release, and field quality. You will oversee three technology platforms: capital equipment, perfusate solutions, and EO sterilized disposables, ensuring inspection readiness and on-time delivery.

The role collaborates with Manufacturing, Supply Chain, and Engineering, reporting to the SVP of Quality and Regulatory.