Shire Jobs

Provide quality support for products in our Advanced Materials Handing business unit. Lead cross-functional product, process and customer issue resolution teams using tools such as Model-based problem solving, 8D, Six Sigma DMAIC and Statistical Process Control to ensure effective corrective and preventive actions and closure within timing goals. Lead meetings with customers as necessary to provide status of corrective and preventive actions. Generate, analyze, and report on the levels of product quality within the assigned product areas, including Pareto, Statistical Process Control, and Process Capability Studies. Participate in material disposition decisions to support ongoing production for areas of responsibility. Represent Quality as a team member on New Product Development Teams (development of FMEA, inspection and control plans, data collection and analysis, etc.) to ensure products released to manufacturing meet quality performance goals; approve Engineering Change Requests (ECRs). Provide input into validation and qualification studies for product, process and supplier change management activities. Facilitate change management projects within assigned product areas and lead change board (CCMB) meetings. Lead Quality planning and review activities for the business unit in Flywheel meetings. Participate in continuous improvement (Lean and Six Sigma projects) within assigned manufacturing areas and quality processes. Author and/or review procedures, work instructions, test specifications, and other documents. Support ISO registration, customer and supplier audits as a subject matter expert, as needed.