Risk Management Engineer

Job DescriptionThis position has responsibility and authority for:
90% Risk Management document support, 10% quality advocacy and project management.
Risk ManagementParticipate in Risk Analyses for new and existing products, including review of both hardware and software.Using data from Post Market reviews, update risk documentation as needed, following confirmations with Project QEs and Design Engineering.Work with Design Engineering to maintain tracing of risk to requirement to test.Work with Manufacturing Engineering on process risk documentsParticipate in review of technical and quality information for regulatory submissions.Quality Process ImprovementsAs needed, participate in Quality process improvement projects (CAPA, Process NonConformance, Quality Plans, other process improvements)
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