Staff Quality Engineer (QMS)

Job description

Job Summary: The Staff Quality Engineer operates at a system and enterprise level, driving quality performance across the value chain by defining, standardizing, and continuously improving processes that enable consistent execution and scalable production. This role establishes how customer, regulatory, and operational requirements are translated into a cohesive and effective quality system across programs and sites. Duties and Responsibilities: - Diagnose and improve QMS effectiveness by identifying breakdowns in CAPA, audit outcomes, process adherence, and escape trends, and driving systemic corrective actions - Define and drive quality system strategy across the value chain, including supply chain, production, and customer/field performance - Establish how requirements are translated into standardized, scalable processes across programs and sites - Ensure quality systems enable consistent execution, production scalability, and operational efficiency - Identify systemic gaps between documented processes and actual execution across the value chain and drive enterprise-level alignment - Lead system-level improvements in CAPA effectiveness, process standardization, and quality syste...