Product Quality Engineer

Overview

ABOUT ORGANOX

OrganOx is a global medical device company focused on improving organ transplantation outcomes. The OrganOx Metra normothermic machine perfusion (NMP) system for liver transplantation has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The Product Quality Engineering team monitors, understands, and improves product performance of the OrganOx Metra (a Class III medical device). The team works with Product Sustaining Engineering and Contracted Suppliers to establish quality control and management processes for externally built products and components, including sterilization, microbiology, supplier management, and contract manufacturing processes.

The Product Quality Engineer will have strong hands-on technical skills to analyze product quality issues and collaborate cross-functionally to resolve problems related to product quality. The successful candidate is collaborative, communicates well, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer.

This is a flexible, on-site role in our Madison, NJ office.

Major Responsibilities

• 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 diagnose field failures
• Analyze and trend 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
• Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures
• 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 all company policies

Requirements

Skills and Experience

Qualifications

Note : The description indicates the job is hybrid in location.

Benefits

The pay range for this position is $105,000 - $115,000 annually, with a 10% target annual bonus and benefits.

OrganOx offers competitive compensation and comprehensive benefits from day one, including health, dental, vision, flexible spending accounts, and a 401(k) plan with company matching after 90 days. Paid time off, holidays, additional leave benefits, employee discounts, and access to our onsite wellness facility are provided. OrganOx supports work-life balance and opportunities for ongoing professional development.

Equal Opportunity Employer — We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, status, protected veteran status, genetic information, or any other characteristic protected by law.

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