Senior Quality Engineer, Combo Product External Quality

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Senior Quality Engineer – Combination Products External Quality is responsible for the quality of assigned suppliers/contract manufacturers to ensure business objective are me with regards to on time delivery of product while assuring compliance to AbbVie requirements, applicable external regulations, and standards.   Products include injection molded components, and critical device components used to manufacture AbbVie On Body Injection Delivery Systems.  

Responsibilities:

• Support supplier quality development projects and continuous improvement activities.
• Investigate/coordinate supplier quality issues resolution with the appropriate department, including the dispositioning of non-conforming product, event, deviation, and market complaints. 
• Initiate and follow up on Supplier Corrective Action Requests (SCARs).
• Validate supplier corrective actions involving design and/or process changes to ensure they are robust, sustainable, and implemented for similar potential concerns across manufacturing lines and/or suppliers
• Coordinate supplier change notifications and ensure supplier changes are appropriately assessed for impact and change plans opened to mitigate any impact to AbbVie product / processes.
• Work with Product Development and Manufacturing/Process Engineers to develop appropriate receiving inspection test methods, sampling plans and acceptance criteria for new and existing components and materials, including first article inspection.
• Review and monitor s