What are the responsibilities and job description for the Quality Engineer - Post Market position at Sunrise Systems, Inc.?
Our client, a leading Medical Devices Manufacturing Company is looking for Quality Engineer - Post Market and This is for an initial duration of 12 Months Contract – San Diego, CA
Job Title : Quality Engineer - Post Market
Job Id : 25-06208
Location : San Diego, CA
Duration : 12 Months Contract
Position Type : Hourly Contract Position (W2 only)
Hybrid 4 days on site
Job Summary
The Sr. Specialist, Post Market Quality position reports directly to the Director, Post Market Quality, Field Action.
The Sr. Specialist, Post Market Quality position is responsible for working with Medical Management Solutions (MMS) on various post market quality issues, including, Supporting timely execution of field actions within North America for MMS related field actions.
Responsibilities
Performs Global Regulatory Impact Assessment (GRIA) for North America and serves as coordinator to all other regions / countries for GRIA completion maintaining all regional documentation in the field action file
Assists in preparation of distribution reports as needed for field action preparation
Support MMS field action team in customer letter drafting, gathering stakeholder feedback, and finalization.
Qualifications :
BA or BS degree, with minimum of 1-2 years relevant experience in the medical device, in vitro diagnostics, or pharmaceutical industry.
Preferred Experience & Education :
Experience with post market surveillance and / or post market quality.
Expertise in participating in both internal and external audits.
Experience in 21CFR 806 and Canada Recall Regulations.
Experience with medical devices containing software.
Experience working within software management systems, such as, ERP and QMS systems.
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