Complaint Coordinator Lead III

Overview:

Job Summary

Responsible for monitoring the inquiry system. Responsible for assuring streamlined and efficient systems for complaint resolution. Responsible for product family specific sytems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards.

Responsibilities:

• Ensures timely and thorough review of all complaints and inquiries, prioritizing potentially reportable events.
• Escalate any potentially reportable complaint or inquiry, communicates with the crossfunctional team and management, drives the post market Risk Analysis Worksheet (RAW) process through completion.
• Communicates updates on escalations, priorities, and complaint status to leadership and in various meetings.
• Chairing meetings and providing guidance and direction to the RAW team.
• Trains and develops subordinates, as appropriate, to achieve duties and responsibilities.
• Coordinates and/or attends meetings with appropriate departments for specific customer complaint issues, determination and resolution of root causes for complaints.
• Analyze post market data for trends, ensure necessary escalations, investigations and CAPA actions are taken to remediate negative trends.
• Responsible for maintaining Complaint KPI data and reporting as necessary.
• Responsible for gathering complaint and RAW data for Post Market Surveillance and updating the RA reports including assessing newly identifed risks.
• Follows regulatory requirements for complaint management.
• Establish and maintain a system to review literature and social media for complaints
• Manages tasks supporting complaint investigations, including returned parts and external assignments.
• Supports investigation activities and provides guidance for resolving product mal functions.
• Will work cross-functionally to obtain information required to support regulatory and business decisions.
• Performs other related duties as assigned.

• Medical Affairs
• R&D
• Regulatory Affairs
• IT /Cybersecurity
• Global Affiliates
• Operations
• Other technology centers

Qualifications:

Minimum Knowledge & Experience for the position:

• Bachelor's degree in relevant field (i.e. Life Science, Biochemistry, Engineering or similar
• Eight years (with a Bachelor's) or five years (with a Master's) relevant experience.
• Three to five years of supervisory or people management experience.

Skills & Capabilities:

• Strong knowledge of FDA, Medical Device and IVD regulations and quality systems related to complaints, and statistical techniques and the ability to train others related to these requirements.
• Strong customer focus and continuous improvement mentality.
• Excellent written and oral communication skills
• Ability to drive Risk Management, escalation and complaint closure processes.
• Critical thinking skills, including the ability to analyze and trend data and communicate concerns as needed.

Travel requirements: N/A