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AbbVie is seeking a Senior Quality Engineer – Combination Products External Quality to ensure the quality of assigned suppliers and contract manufacturers. This critical role ensures business objectives are met regarding on-time delivery of products while assuring compliance to AbbVie requirements, applicable external regulations, and industry standards.
You will be responsible for products including injection molded components and critical device components used to manufacture AbbVie On Body Injection Delivery Systems. This position offers the opportunity to work with cutting-edge medical device technology and contribute to patient safety and product excellence.
Your responsibilities will include supporting supplier quality development projects and continuous improvement activities, investigating and coordinating supplier quality issue resolution, and managing the disposition of non-conforming products, events, deviations, and market complaints. You will initiate and follow up on Supplier Corrective Action Requests (SCARs), validating supplier corrective actions involving design and process changes.
This role requires collaboration with Product Development and Manufacturing/Process Engineers to develop appropriate receiving inspection test methods, sampling plans, and acceptance criteria. You will coordinate supplier change notifications and ensure supplier changes are appropriately assessed for impact on AbbVie products and processes.