OrganOx

QA Engineer

• Lead root-cause investigations in response to customer complaints
• Support hands-on analyses of returned products to identify root causes of failures
• Support development of investigation criteria and test methods to properly diagnose and root cause field failures
• Analyze and trend on product performance data to provide recommendations for product improvements
• Raise Supplier Corrective Action Reports (SCARs) in response to product performance trends and support timely closure of SCARs
• Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures
• Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts
• Support CAPAs, Escalations, and engineering investigations in response to field quality issues
• Participate in the development and review of engineering change orders that impact product quality activities
• Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
• Adhere to OrganOx’s Code of Conduct and company policies
• Collaborate with Product Sustaining Engineering and Contracted Suppliers to set quality control and management processes including sterilization, microbiology, supplier management, and contract manufacturing processes

Product Quality Engineer