Product Quality Engineer

Responsibilities

• Support root-cause investigations and hands-on analyses of returned products to identify failures
• Perform decontamination processes for returned products in accordance with established procedures
• Gather relevant case details, including service reports and system data, to support complaint evaluations
• Execute laboratory work such as monitoring test circuits and preparing equipment for evaluation
• Support the development of investigation criteria and test methods to diagnose field failures
• Raise and support the timely closure of Supplier Corrective Action Reports (SCARs)
• Work cross-functionally with engineering teams and suppliers to implement manufacturing and inspection changes
• Support CAPAs, escalations, and engineering investigations related to field quality issues
• Participate in the review of engineering change orders and perform DHR and PFMEA reviews

Requirements

• Bachelor's degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.)
• 0-2 years of hands-on engineering experience in medical devices, pharmaceuticals, or another regulated industry
• Excellent technical report writing skills
• Proficiency with MS Office products (Word, Excel, Visio, Project, PowerPoint, etc.)
• Ability to travel 10-20% domestically and internationally

Preferred Qualifications

• Prior experience performing complaint investigations
• Experience handling laboratory materials and conducting hands-on lab investigations
• Familiarity with quality engineering principles such as SCARs and CAPAs

Benefits

• Competitive compensation and comprehensive benefits available from day one
• Health, dental, vision, and disability coverage
• Flexible spending accounts
• 401(k) retirement plan with company matching after 90 days
• Paid time off, holidays, and additional leave benefits
• Employee discounts and access to an onsite wellness facility

About the Company

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. A pioneer in normothermic machine perfusion (NMP), the company's flagship platform, the metra®, is used globally to keep donor livers in a metabolically active state, increasing the number of organs available for transplant. OrganOx is part of the Terumo Group.