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Position Details
Responsibilities
Leads and participates in formal problem-solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes, and Client-side findings. Supports the Director, RAQA for all Quality and Regulatory plans, actions, implementation, and upskilling as the Business grows. Leads overall site compliance efforts. Regulations in scope: FDA applicable to class I and class II medical devices including 510k clearances. Prepare documentation for regulatory meetings with the FDA. Completion of essential functions includes the effective application of Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, the determination of Operating Characteristics for Sampling Plans, and statistical analysis to effect quantifiable product and process improvements. Implements process and softwar...