Medical Device Quality Assurance Investigations Consultant

Indianapolis, IN

Job ID: 122595 Industry: Med

Medical Device Quality Assurance Investigations Consultant

Project Description:

The client is currently looking for a Quality Assurance consultant focusing on investigations and deviations for a remediation project.

Day to Day Responsibilities:

This client is looking for a Quality Assurance consultant to come in and resource a new non-conformance system that handles investigations for the remediation project. They will be responsible for performing discrepancy and non-conforming investigations to identify the root cause and identify appropriate corrective and preventive actions to prevent recurrence of the event. They will be filling in gaps in processes and walking through regulations. They will reviewing investigation reports for thoroughness and accuracy, ensuring that the discrepancy disposition is fully supported by documented evidence. They will provided quality oversight for  deviations  and compliance questions related to project scope. Be able to follow and assisted with the site remediation plan to address CAPAS and deviations  within the scope of the FDA observations.  They want someone with a technical background with at least 5 years’ experience in the medical device industry. Working with remediation projects is a huge plus.

Required Skills:
Medical Device
Non- conformance

Remediation Project

Job Type: Contract 

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