Interface & steer cross-functional team engagements across Business Units, Central Engineering, Operations, Quality, Supply Chain and Procurement to meet department objectives
Drive DFM, technology & manufacturability readiness for new package & complex derivative platforms for effective POR freeze to new product industrialization
Partner with OSATs to deliver assembly readiness for new product qualification. Key activities include process flow & BOM setup, risk analysis & mitigation, process characterization, lookahead assessment, qualification and CAB preparation leading to first part release
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Performs ongoing assessment and allocation of resources within study team to ensure balanced workload for quality administrative support
Ensures rCTMAs have the required level of administrative knowledge and skills to successfully deliver to protocol and study requirements
Is responsible for managing and addressing rCTMA performance and quality performance indicators, procedures and tools in accordance with GCP, ICH, SOP’s, and local regulations.
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