Sr Quality Assurance Manager - Vascular - (Morrisville, NC)
PRINCIPAL RESPONSIBILITIES: * Serve as Vascular management representative per 21 CFR Part 820 and ISO 13485, ensuring that a quality system is established, implemented, and maintained in accordance with appropriate standards and/or regulations, reporting on the performance of the quality system to executive and top management. * Manage Quality Systems personnel to ensure goals are set and achieved. * Lead business unit in data collection and analysis. Define methods and support analysis including risk assessments, Health Hazard Evaluations, and support harmonization activities. * Manage the escalation and compilation of details necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products is warranted. * Collect, summarize and evaluate data for management review meetings and to identify program weaknesses and make improvements in procedures or oversight of the program.
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From American Listed - 1 month ago