Hybrid Product Quality Engineer

at OrganOx

• Job title: Product Quality Engineer
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Madison, United States

About the role

• Product Quality Engineer working at OrganOx to enhance organ transplantation technologies. Responsible for quality testing, analysis, and continuous improvement in a collaborative environment.

Responsibilities

• ABOUT ORGANOX:
• OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Product Quality Engineer to join our team.
• Position Summary
• The Product Quality Team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance, in addition to owning quality processes within the service organization.
• The Product Quality Engineer will be technical, hands-on, and customer focused with an ability to analyze, diagnose and test product quality issues. The successful candidate is accountable, collaborative, has excellent communication and problem solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer.

Requirements

• Requirements
• Major Responsibilities
• Under direction from the Senior Product Quality Engineer, the Product Quality Engineer will:
• · Conduct hands-on analyses of returned products to identify root causes of failures
• · Develop 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
• · Perform Quality trending of Service data and conduct investigations to identify causes of Servicing and Service-related complaint trends, including issues in Servicing workmanship and Out of Box failures.
• · Review the output of Servicing and related Complaint or Non-Conformance Investigation activities to ensure that the resulting work complies with all regulatory and service requirements, as well as facility, divisional, and corporate objectives for defect prevention and continuous improvement.
• · Audit and review Complaint Investigations and records of Servicing activities to ensure they are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system.
• · Analyze service-related PFMEAs and other activities to support pre-market and post-market risk management activities
• · Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations and Servicing records
• · Foster supplier relationships and support Supplier corrective action requests
• · Support Product Transfer teams by aligning on quality requirements and processes for new or transferred products
• · Plan, develop, and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, and inspection method validations
• · Participate in the development and review of engineering change orders that impact servicing activities
• · Work with Engineering to design and implement tooling and fixturing required to perform servicing activities and implement error-proofing (Poke-Yoke) in those stations
• · Work cross-functionally to support implementation of changes in servicing and inspection procedures to mitigate field failures.
• · Support CAPAs, Escalations, DCNs, and other engineering projects to address and resolve field quality issues, ensuring timely implementation and compliance with quality standards
• · Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
• · Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.
• While the above key responsibilities are the main elements of the titled job the Vice President Quality may at times request other tasks deemed to be within their capabilities.

Benefits

• At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.
• We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.