Director of Quality Operations : Class II/III Medical Devices

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
• Class II/III device experience preferred
• 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