Product Quality Engineer

🔬 Product Quality Engineer (Sterilization) | Class III Medical Devices 📍 New Jersey (On-site) | Competitive Salary + Bonus This is an entry-level hands-on quality engineering hire with a commercial stage organ technology company pioneering normothermic machine perfusion technology used in transplantation worldwide. Reporting into the Senior Manager, Product Quality Engineering, you will play a key role in monitoring and improving the performance of a Class III medical device that has already supported thousands of transplants globally.Working closely with Product Sustaining Engineering, contracted suppliers, and cross-functional engineering teams, you will lead hands-on investigations of returned product and contribute to quality processes spanning sterilization, microbiology, supplier management, and contract manufacturing.What you will own:Hands-on complaint investigations and root cause analysis of returned productFull decontamination of returned product per established proceduresLab work including monitoring test circuits and preparing equipment for evaluationDevelopment of investigation criteria and test methods to diagnose field failuresRaising Supplier Corrective Action Reports (SCARs) and supporting their closureSupporting CAPAs, escalations, and engineering investigations in response to field quality issuesDHR, Service History, and PFMEA reviews in support of complaint investigationsCross-functional collaboration to implement manufacturing and inspection changesWhat you must have:Bachelor's degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, or equivalent)0-2 years of hands-on engineering experience in Medical Devices, Pharmaceuticals, or another regulated industryFamiliarity with quality engineering principles including complaint investigation, SCARs, and CAPAsExcellent technical report writing skills and strong MS Office proficiencyStrong attention to detail and a "do it right the first time" mindsetPrior complaint investigation or hands-on lab experience preferred