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The Mullings Group · Itasca, Illinois
Quality Engineer, Complaints and CAPA
Organ Recovery Systems | Itasca, IL | Full-time, On-site
About Organ Recovery Systems
Organ Recovery Systems is the original innovator in organ preservation. Its LifePort Kidney Transporter, the first portable hypothermic machine perfusion system, has preserved more than 275,000 donor kidneys and is backed by more than 60 clinical studies. The company's mission is to honor organ donation by giving transplant teams the tools they need to get more kidneys to the patients waiting for them.
The Role
As Quality Engineer for Complaints and CAPA, you'll lead investigations of returned and field-reported devices, find out what went wrong and why, and turn those findings into lasting improvements. You'll work across a rare mix of products, including capital equipment with firmware, sterile disposables and preservation solutions. You'll partner closely with Engineering, Regulatory, Manufacturing, Service and suppliers. This is an individual contributor role reporting to the Managing Director, Regulatory and Quality.
Investigate and document complaints for capital equipment, disposables and serviced devices
Triage complaints with the Helpline, Engineering and Manufacturing to set scope, risk and escalation
Escalate safety concerns quickly and support timely regulatory reporting decisions
Lead CAPAs that come out of complaint investigations and trends
Run the Complaint Review Board and support the CAPA Review Board
Build complaint and CAPA metrics for management review and post-market surveillance
Feed findings into risk management files and support internal audits, external audits and FDA inspections
What You Bring
Bachelor's degree in a technical field such as engineering or science (a master's degree with 2+ years of experience also qualifies)
4+ years of medical device experience in complaints, CAPA, quality engineering, supplier quality, service or post-market quality
Working knowledge of complaint handling, CAPA, risk management (ISO 14971) and MDR reporting
Hands-on root-cause analysis skills, such as fault-tree analysis and statistical methods
Clear, audit-ready technical writing and confidence presenting to cross-functional teams
Nice to Have
CQE, CQA, CRE or Six Sigma certification
Familiarity with statistical software and electronic QMS tools
Exposure to FDA QMSR, ISO 13485, MDSAP and EU MDR
Why Join
Do mission-driven work, where every investigation protects a donor's gift and a patient waiting for a transplant
Investigate hardware, firmware, disposables and solutions, a breadth few quality engineering roles offer
Gain real visibility by leading the Complaint Review Board and presenting to leadership
Join a company that has set the standard of care in kidney preservation for more than 20 years
Details
| Company | The Mullings Group |
| Location | Itasca, Illinois |
| Type | FULL TIME |
| Niche | Industrial and production engineers |