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PMV Coordinator (Data Entry)- 53720877TV

Job Code: 53720877
Job Location: North Haven, CT
Category: Admin
Last Updated: 10/17/2016
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Position Summary: The PMV Data Entry Coordinator position is responsible for entering, monitoring and tracking product complaints in order to assure compliance with competent authorities worldwide.
• Duties include complaint intake, updating complaint files with new information, Government complaint report submissions (e.g. 3500A) and data preparation for trend analysis.
• The candidate must have excellent customer services skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective.
• This position requires an eye for detail and excellent organizational skills.
Essential Duties and Responsibilities:
• Working within an office environment as a team with PMV Analyst at various levels.
• Complaint entry using current systems.
• Maintain the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union), Canadian Medical Device Regulations, Japan MHLW, China SFDA and Australian Regulations.
• May include preparation and submission of Medical Device reports with focus on accuracy, precision and urgency.
• Tracking and trending of complaints.
• Monitor quality and timeliness of complaint files.
• May provide, present data and trends to other departments as necessary.
• Ensure obligation to internal and external customers are performed accurately and timely.
• Involvement with Engineers, Managers and R&D as needed to assure all trending is appropriately communicated throughout the organization.
• Medical device experience desirable.
• Self-starter with proven ability to successfully work with minimal supervision.
• Strong operating knowledge of Microsoft Office to include Word, Excel and Outlook.
• Knowledge of quality control concepts desirable. ¿ Customer service skills.
• Detailed oriented and organized.
• Ability to communicate verbally and in writing.
• Capable of handling multiple assignments simultaneously.
• High School Diploma
• Some college preferred
• Office work: usual office environment and frequent* sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping and occasional* climbing.
• Frequent use of eye, hand and finger coordination enabling use of office machinery.
• Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.
• Light physical effort required in handling objects up to 20 pounds occasionally and/or up to 10 pounds frequently.
• May occasional be required to assist and/or observe activities within a biohazard laboratory setting which would require the use of personal protective equipment.
• Occasional overtime.
Other Key Notes: -
• Attention to detail, Excel skills, TEAM PLAYER with a great attitude.
• Compliance to FDA regulations means 100% correct, 100% of the time, attention to detail is key.
Equal Opportunity Employer
For more information about this position, please contact the Entegee New Hope, MN office at
763-577-9000 or
Please reference job # 53720877TV


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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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