Entegee Data Entry 53310776 - JE in Boulder, Colorado
Data Entry 53310776 - JE
Job Code: 53310776Job Location: Boulder, COCategory: AdminLast Updated: 10/21/2016Apply Now!
The PMV Analyst Coordinator position is responsible for monitoring, tracking and trending 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 entry-level 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 obligations 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.
• High School Diploma
• Some college preferred
• 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.
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or email@example.com.
Please reference job # 53310776JE
Equal Opportunity Employer