Data entry Clerk/ Documentation Specialist

 
Location: North Haven, Connecticut
Posted On: 6/12/2017
Job Code: 7460_DE_CT
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Job Description
 
Position Summary:
• The PMV Analyst 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.

Duties and Responsibilities:
• Working within an office environment as a team with PMV Analyst at various levels:
• Complaint entry using current Company 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.

Qualifications:
• Medical device experience desirable.
• Self-starter with proven ability to successfully work with minimal supervision.
• Strong operating knowledge of MS 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.

Education:
• High School Diploma
• Some college preferred

Experience:
• No previous experience required.
Category:Non-IT  code:new
 
 
Job Requirements
 
 
MS Office, Excel, Data entry, Outlook, Word
 

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Contact Details
 
Recruiter
Sparsh Patel
 
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