Team Lead, Complaint Determination (Guadalajara)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

Position Overview

The Team Lead of Complaint Determination will work under the guidance of the Supervisor Complaint Determination, General Product Monitoring and will complete and oversee a team of individuals to ensure compliant complaint determination decisions are made. This person is responsible for executing and leading all aspects of the complaint determination process. They will follow established global regulations and processes for complaint determination.

Responsibilities

• Review and execute the process to determine if an inquiry object meets the definition of a medical device complaint.
• Assign cases, determined to be complaints, with an appropriate category to allow for better assignment at the next phase of the complaint handling process.
• Assign cases containing non-complaint feedback with an appropriate category to allow for better trending and reporting activities.
• Reassess inquiry records when new information is received.
• Lead, provide guidance, and train a team of individuals executing the complaint determination process.
• Provide coaching and feedback to direct reports.
• Identify process improvement opportunities to enhance surveillance and to increase efficiency.
• Assist in the development of protocols and standards to meet quality specifications and recommend procedural changes. Create and update documentation master files.
• Onboard team members and support ongoing development of the team.
• Perform other complaint handling responsibilities as required.

Required Leadership & Interpersonal Skills & Behaviors

• Ability to handle team interpersonal conflicts and find an acceptable resolution.
• Effective verbal communication and excellent technical writing skills.
• Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision.
• Ability to organize and judge priorities.
• Comfortable communicating to all levels and functions.
• Strong attention to detail.
• Ability to work in a team environment.

Required Skills and Competencies

• Solid understanding of QSR and/or ISO 13485.
• Demonstrated knowledge of Microsoft Office.
• Working knowledge of complaint handling functions of a medical device company.
• Working understanding of TrackWise and SalesForce CRM preferred.
• Effective written and verbal communication skills.
• Ability to generate and maintain accurate records.

Education and Experience

• 3-5 years’ experience in medical device complaint handling, or more than 3 years’ experience within Medical Device Quality Systems and/or equivalent combination of education and experience.
• Prior people leadership experience required.