Medical Device Quality Manager - Software (SaMD/SiMD)

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 Manager, Medical Device Quality – Software will act as the global product quality lead in support of a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Key responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and CAPA, with oversight of complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. This position will lead and participate in projects to enhance and maintain safety and performance of on-market products, interfacing with supplier and internal groups to drive product quality. This position will be located at our Medical Device Center Headquarters in Waukegan, IL and report directly into the Senior Manager of Medical Device Quality.

• Leads resolution of quality issues with on-market device software & mobile apps. Drives investigations related to product nonconformities. Define and implement corrective and preventive actions.
• Serves as the Quality approver of any device software or mobile app complaints and complaint trend evaluations.
• Serves as the Quality reviewer and approver of device software design control tasks or IT change requests in Service Now for device software and mobile apps
• Serves as the Device QA approver of post-market surveillance and clinical evaluation plans and reports for SaMD/SiMD products.
• Serves as the Medical Device Quality SME on software classification review board
• Support risk management / FMEA activities for device software & mobile apps.
• Drive change management process for device software / mobile app launches and market exp