Entegee PMV Coordinator (Data Entry)- 53720877TV in North Haven, Connecticut
PMV Coordinator (Data Entry)- 53720877TV
Job Code: 53720877Job Location: North Haven, CTCategory: AdminLast Updated: 10/17/2016Apply Now!
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 firstname.lastname@example.org.
Please reference job # 53720877TV