Risk Management Engineer

Job Description

This position has responsibility and authority for:

90% Risk Management document support, 10% quality advocacy and project management.

• Risk Management
  • Participate 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 documents
  • Participate in review of technical and quality information for regulatory submissions.
• Quality Process Improvements
  • As needed, participate in Quality process improvement projects (CAPA, Process NonConformance, Quality Plans, other process improvements)