Quality Engineer

3 weeks ago


Irvine, United States Katalyst HealthCares & Life Sciences Full time

Environment:

Our client is a large medical device manufacturer product manufacturer.

They are currently in need of several contractors to support a backlog of complaints that need to be remediated.

Responsibilities :

This consultant will come from a Medical Device background and will be responsible for remediating existing complaints.

This role is focused heavily on root cause analysis, risk management, data analysis, analyzing reports of defects, and processing issues to determine trends.

This person will need to have supported a complaint process from beginning to end, and be able to determine the root causes of the complaint.

They will also need to have an understanding of FMEAs and how complaints ties into FMEAs.

Strong cross functional skills and communication are a must.

Required:

Medical Device

Complaint Reportability

Risk Management

Root Cause

Trending

Data Analysis

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