Senior Director, Quality Operations – Medical Devices

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

Job summary

Organ Recovery Systems in Itasca, IL seeks a Director of Quality Operations to own manufacturing quality and product release across multiple platforms. You will lead quality oversight of the US contract manufacturer network, drive CAPA and nonconformance resolution, and own field quality and complaint investigations.

The role reports to the SVP of Quality and Regulatory and collaborates closely with Manufacturing, Supply Chain, and Engineering to ensure inspection readiness and continuous

Qualifications

• 10+ years in progressive medical device quality operations.
• 5+ years leading quality teams in regulated manufacturing.
• Experience managing quality through contract manufacturers and supplier networks.
• Strong command of FDA QMSR, ISO 13485, and EU MDR.
• Sterile disposables and EO sterilization experience is a differentiator; aseptic fill background helps.

Responsibilities

• Own manufacturing quality and product release.
• Lead quality oversight across ORS's US-based contract manufacturer network.
• Drive CAPA and nonconformance resolution.
• Own field quality and complaint investigation.
• Report to the SVP of Quality and Regulatory and partner with Manufacturing, Supply Chain, and Engineering.

Skills

Quality leadership

Regulatory compliance

Contract manufacturing

QMS management

CAPA management

Sterile disposables

EO sterilization

ISO 13485

FDA QMSR

Aseptic fill

Job description

Organ Recovery Systems in Itasca, IL seeks a Director of Quality Operations to own manufacturing quality and product release across multiple platforms. You will lead quality oversight of the US contract manufacturer network, drive CAPA and nonconformance resolution, and own field quality and complaint investigations.

The role reports to the SVP of Quality and Regulatory and collaborates closely with Manufacturing, Supply Chain, and Engineering to ensure inspection readiness and continuous