Senior Quality Engineer

The Mullings Group; Itasca (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Organ Recovery Systems in Itasca, IL is seeking a Quality Engineer for Complaints and CAPA to lead investigations of returned and field-reported devices and drive improvements. This individual contributor role reports to the Managing Director, Regulatory and Quality.

You will collaborate across Engineering, Regulatory, Manufacturing and suppliers to triage, investigate and close out CAPAs, with a focus on risk management and FDA compliance in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in engineering or science required.
• 4+ years medical device quality experience (complaints, CAPA, MDR).
• Experience with capital equipment, sterile products, packaging or labeling.

Responsibilities

• Investigate and document complaints for capital equipment, disposables and serviced devices.
• Triage complaints with Helpline, Engineering and Manufacturing to set scope, risk and escalation.
• Escalate safety concerns quickly and support regulatory reporting decisions.
• Lead CAPAs arising from complaint investigations and trends.
• Run the Complaint Review Board and support CAPA Review Board.
• Build complaint and CAPA metrics for management review and post-market surveillance.
• Support risk management files and internal/external audits and FDA inspections.

Skills

Root cause analysis

Audit-ready writing

Cross-functional

Statistical methods

Education

Bachelor's degree in engineering or science

Tools

Statistical software

Electronic QMS tools

Job description

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.

What You'll Do

• 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
• Experience with capital equipment, sterile products, packaging or labeling
• 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
• Experience leading review boards or preparing management review inputs
• 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