Justine Zeller

About Justine Zeller

I am a dedicated quality professional with a background in quality and design for medical…

Experience

1. Quality Engineer

   Network Partners Group

   Jul 2021 — Present · US

   Currently supporting a medical device client by leading risk management efforts as part of an acquisition and integration project. Driving development of an integrated product and process risk management system, including writing standard operating procedures and designing standardized risk management templates. Spearheading the development and implementation of a comprehensive strategy to remediate acquired risk management files across multiple product families into this new system. Developing and delivering training to client teams on risk management principles, procedures, and tools to ensure cross-functional alignment and full compliance with risk management standards. Previously supported this client by performing a retrospective review of complaints, nonconformances and other CAPA feeder systems to determine appropriate risk escalation actions; and by investigating new product complaints.Previously supported an orthopedic medical device client with FDA and EU MDR remediation of multiple product lines. Identified and addressed gaps in legacy product DHFs across a variety of areas including design controls, risk management, verification and validation activities, process quality, and design transfer. Collaborated with R&D engineering, regulatory affairs, clinical affairs, supplier quality, and other functions to ensure gaps were met and full product compliance was achieved.Network Partners Group provides expert resources and consulting services to the medical device, pharmaceutical, and biotech industries. Network Partners Group deploys disciplined processes, industry expertise, and proven methods to help you strategically complete your critical packaging engineering, labeling, regulatory, quality, and project management projects.

Education

• Carnegie Mellon University

  Master of Science - MS, Mechanical Engineering

  2019 — 2019

• Carnegie Mellon University

  BS in Mechanical Engineering, Additional Major in Biomedical Engineering, Minor in Hispanic Studies

  2015 — 2019

Skills

• Matlab
• Project Management
• Solidworks
• Python
• Machine Shop Training
• Digital Photography
• Written Communication
• Teamwork
• Social Media
• Visual Studio Team System
• Microsoft Office
• Photoshop