Senior Quality Engineer

Quality Engineer, Complaints and CAPAOrgan Recovery Systems | Itasca, IL | Full-time, On-site

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About Organ Recovery SystemsOrgan 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 RoleAs 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 DoInvestigate and document complaints for capital equipment, disposables and serviced devicesTriage complaints with the Helpline, Engineering and Manufacturing to set scope, risk and escalationEscalate safety concerns quickly and support timely regulatory reporting decisionsLead CAPAs that come out of complaint investigations and trendsRun the Complaint Review Board and support the CAPA Review BoardBuild complaint and CAPA metrics for management review and post-market surveillanceFeed findings into risk management files and support internal audits, external audits and FDA inspections
What You BringBachelor'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 qualityExperience with capital equipment, sterile products, packaging or labelingWorking knowledge of complaint handling, CAPA, risk management (ISO 14971) and MDR reportingHands-on root-cause analysis skills, such as fault-tree analysis and statistical methodsClear, audit-ready technical writing and confidence xzbcwsv presenting to cross-functional teams
Nice to HaveCQE, CQA, CRE or Six Sigma certificationExperience leading review boards or preparing management review inputsFamiliarity with statistical software and electronic QMS toolsExposure to FDA QMSR, ISO 13485, MDSAP and EU MDR
Why JoinDo mission-driven work, where every investigation protects a donor's gift and a patient waiting for a transplantInvestigate hardware, firmware, disposables and solutions, a breadth few quality engineering roles offerGain real visibility by leading the Complaint Review Board and presenting to leadershipJoin a company that has set the standard of care in kidney preservation for more than 20 years