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Senior Quality Engineer- Post Market Compliance - (Mansfield, MA)

SUMMARY OF POSITION: This position is expected to lead and support key post market quality efforts within the DVT NI and Patient Care Businesses. They will coordinate the investigation of post market assessments, ensure alignment with functional groups, carry out product notifications related to field actions, and deployment of corrective and preventive actions. This role is focused on maintaining and improving process and product performance and monitoring. As such, this position is expected to: * Collaborate with all pre and post-production functions (R&D, manufacturing, post market vigilance, CAPA, change development, Supplier Quality, etc.) to ensure the proper application, use and updates of risk management files following product launch. * Ensure Risk Management Files are maintained per defined schedules and frequencies. * Provide assessment of post-market risk related to field issues and provide response to regulatory body inquiries as necessary.


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Posted in Mansfield, MA, Technical Support
From Equest - 1 month ago