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Global Complaints Mgr.         Salary: $125,000 - $140,000
Atlanta, GA

Submit resume to Greg Taylor - gtaylor@excelsiorsp.com
Reference Job 01570770


Description
This position manages the Global Complaint Management & Field Action process and organization including functions & representatives worldwide to assure the accurate & timely input & analysis of information and compliance with international (e.g. FDA, ISO), regional (e.g. EU) & local country (e.g. France, Japan) regulations.

The incumbent is responsible for assuring accurate & timely investigations & follow-up of Adverse Events & major product problems, and meeting stringent regulated reporting requirements. Accountable for effective investigations, analysis and recommendations to management on critical complaints, product issues and negative complaint trends, as well as continuous improvements to the global complaint management system.

Primary Responsibilities:

• Manages the Global Complaint Management (GCM) process & organization including international customer service representatives, product verification centers, and responsible Quality personnel.
• Assures Accurate & Timely Reporting, Investigations & Follow-Up by All Constituents Involved in Process.
• Investigate & Communicate Critical and Major Complaints, Issues and Changes in Trends.
• Manages the Field Action Assessment & Product Recall Process.
• Lead Continuous Improvements & Enhancements to Both the Overall Process & the GCM System.
• Nurture, Grow & Develop People.

Minimum requirements Minimum Education Required:
- BS/BA in Science or Health related discipline
Preferred Level:
- Advanced degree in Science or Health related discipline

Minimum Experience Required:
- 5-8 years total GxP/Quality Assurance/Systems experience in Healthcare Industry
- 2-3 years Complaint Management experience
- 2 years of Management experience
- Solid understanding of Medical Device/Pharmaceutical regulations.

Preferred Level:
- Medical Device / Pharmaceutical Product Development, Customer Service or Manufacturing experience in addition.

Minimum Skills Required:
- Strong leadership skills for a high performance team
- Ability to develop plans to achieve goals and objectives that have significant impact for the company
- Basic understanding of database management 
- Creative and innovative thinking for analysis and application of problem solving techniques

Preferred Level: 
International experience 
Applied knowledge & experience with statistical applications
Required years of experience Seven - Ten Years.