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Job summary:
Evaluate and resolve complaints, initiate CAPAs, analyze complaint data, gather additional data as needed, and provide feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations

 KEY AREAS OF RESPONSIBILITIES          
•  Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling  process globally  
• Evaluate customer feedback, service records, and other sources of customer  and internal for possible complaint.              
•Initiate complaint in process and applicable tool.                   
•Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint                    
•Communicate with customers, call center reps and FSEs to gather more data  on complaints as needed           
•Confirm complaint condition and determine corrective action (including CAPA as needed)                      
•Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when  needed                      
•Assess if the Risk assessment is covering the hazard in the complaint                   
•Complete all needed records in a timely and accurate manner        
 
JOB OVERVIEW
BG Q&R:
• Leads team of investigators responsible to evaluate, investigate, and resolve complaints.
• Completes initial assessment of reportability and escalate to the manager when necessary to determine action.
• Analyzes complaint data, gathers additional data as needed, and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and complaints.
          
SRRT:
• Leads team of reviewers responsible to review and apply appropriate coding to Service Records as an input to the complaints process.

Markets Q&R:
• Leads team of investigators responsible to screen, evaluate, and monitor complaints (products & non-product) resolution.
• Reviews complaint criticality and initiates necessary containment actions, escalating to the manager to determine action.
• Analyzes complaint data, gathers additional data as needed, and partners cross functionally to provide feedback to the BIU supporting complaint evaluation and/or to the Market Management Review on potential process and quality improvements.
 
Dimensions related to Know-How, Complexity, and Accountability:
• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey- level position. Has a complete knowledge of company products and services.
• Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a project team.

Dimensions Relating to Problem Solving: Thinking environment & -challenge:

• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
• Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems.
• Develops and administers schedules, performance requirements.
• Has budget responsibilities.

Dimensions Relating to Accountability: Freedom to Act, Magnitude, Nature of impact

• Responsible for managing a part of a business process or function.
• Manages, perhaps through subordinate supervisors, the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing. In some instances this manager may be responsible for a functional area and not have any subordinate employees.
• Incumbents at the Manager level may manage only individual contributors and may carry their own targets.
• May manage own budget

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