Product Surveillance Analyst - Minneapolis, United States - INTELLECTT INC

INTELLECTT INC Minneapolis, United States

1 month ago

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Description

Role: Product Surveillance Analyst

Location: Plymouth, MN 55442

Duration: 12 Months on W2

Shift Timings: 8 AM to 4:30 PM

Job Description:

Taking complaints that are returned and doing complaint investigations on that particular complaint device.
They will be using manufacturing and design documentation to determine whether or not to verify the report of the event.
Writing an investigation that summarizes their findings.
Use various electrical, dimensional or functional techniques to determine the root cause of the complaint.
Must be comfortable working with devices which are used by patients and can be contaminated as they will work on returned products. They will be cleaned before it reaches them but still, they must be okay with working on it.
Work in a clean room environment.

Experience/Knowledge/Skills needed for both positions

Comply with FDA regulations and work with multiple cross-functional teams.
Any previous med device complaints handling exp is helpful; Keywords reportability, medical technology, and lab exp.
Excellent documentation and writing skills. Strong oral communication as they need to work cross-functionally a lot.
Problem solving skills.

Education and Experience:

Bachelor's degree preferred (Biology or related) ; 0 to 2 years of experience.
Recent college graduates: have lab exp in academics or have done some internship in healthcare/med device field that has given them reportability/lab-related skills.
Lab Position, recent grads: Electrical engineering concepts, Manufacturing techniques, Optical component, Systems engineering.
Will also consider an Associates degree with 2+ years of experience in med device complaints handling.

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