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.

The Team Lead of Complaint Determination will work under the guidance of the Global Program Manager, Global Product Monitoring and will complete and oversee a team of individuals to ensure compliant complaint determination decisions are made. This is a long-term contract position and 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
• Assists in the development of protocols and standards to meet quality specifications and recommends procedural changes Create and update documentation master files
• Performs 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 strongly preferred

Additional Information

• The position can be remote, hybrid, or in-person. If in-person the preferred location is the Acton, Massachusetts facility.
• Travel is estimated at <5% but will flex depending on business needs.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid  

The candidate for this role may be employed through a third-party partner of Insulet.