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Product Complaints Analyst II - 53706927 - TF

Job Code: 53706927
Job Location: Minnetonka, MN
Category: Quality Engineering
Last Updated: 10/17/2016
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Job Description:
Our customer is looking for a Product Complaints Analyst to work on processes, investigates, and monitors trending and reporting of product defect complaints, serving as primary contact under the company's complaint policy and procedures. Analyzes customer complaints to determine which are regulatory reportable and coordinates Post Market activities with internal, field, and end use customers. Responsible for complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
4 year Technical Degree is needed. Must have 3+ years’ experience as a Medical Device Product Complaints Analyst is needed.  Must have experience with complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 53706927TF
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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