Quality Assurance Manager ##Irvine##CA
Employment Type: Full-Time
The Quality Assurance Manager is responsible for leading the affairs of Quality Assurance for Nihon Kohden America. This role is responsible for maintaining the quality management system (QMS) infrastructure and ensuring it is compliant, simple, effective, efficient, and defensible.This position is responsible for providing oversight for all the elements of the QMS including design control, risk management, complaint handling, CAPA, training, design control, document control, and production and process activities. Additional responsibilities include establishing and sustaining corporate quality goals, managing and improving all aspects of the quality system, managing and conducting internal or external audits as needed. Strong leadership and team building skills are required to manage the Quality Assurance team to ensure quality initiatives are met. Proven experience with medical device, measurement and management techniques, analysis of product and process failures, performing root cause analysis, use of data driven decision making and implementing corrective and preventative actions are required.
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