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Quality Assurance Associate - 60620420 - MU

Job Code: 60620420
Job Location: Miami, FL
Category: Technicians
Last Updated: 02/06/2018
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Job Description:
The Quality Assurance Analyst II on the Post Market team will participate in complaint handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience.  
• Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by the company in a manner consistent with all laws and regulations for medical devices.
• Generate and analyze customer feedback (CF) data to improve product reliability and performance for our customers.
• Assess complaint information for determination of adverse event reporting and/or vigilance reporting.
• High School Diploma or GED.
• Must have 2+ years of experience
• Knowledge of domestic and international quality systems and other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations.
• Ability to drive results, foster teamwork, handle pressure, and provide feedback
• The ideal person for the CAPA role will have some knowledge of the different standards and regulations, as the CAPA requirements are documented there and the record must meet those requirements.
• Proficient in MS Office Suite of products.
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 60620420MU
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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