Director of Quality Operations : Class II/III 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

Director of Quality Operations | Organ Recovery Systems | Itasca, IL

Since 2003, Organ Recovery Systems has protected the donor's gift. Their LifePort Kidney Transporter has preserved over 275,000 kidneys and set the standard for hypothermic machine perfusion worldwide.

Now they're hiring the operational quality leader who keeps three technology platforms, capital equipment, perfusate solutions, and sterile disposables, compliant, on time, and inspection ready.

This is an execution role, not a compliance desk job. You'll own manufacturing quality and product release, lead quality oversight across ORS's US-based contract manufacturer network, drive CAPA and nonconformance resolution, and own field quality and complaint investigation.

You'll report directly to the SVP of Quality and Regulatory and partner closely with Manufacturing, Supply Chain, and Engineering.

What ORS needs:

• 10+ years of progressive medical device quality operations experience, with 5+ years leading quality teams inside a regulated manufacturing environment
• Hands-on 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 real differentiator here; aseptic fill or solutions background helps too

What makes this role different:

• The product you're protecting literally keeps organs alive between donor and recipient
• Three distinct technology platforms mean real variety: reusable capital equipment, perfusate solutions, and EO sterilized disposables
• ORS is open to candidates who could grow into the SVP seat over time