Medical Device Complaint Specialist

Job Summary The Medical Device Complaint Specialist is responsible for evaluating, processing, and investigating product complaints to ensure accurate assessments, regulatory compliance, and timely resolution. This role supports complaint handling activities through complaint coding, reportability determination, data analysis, documentation review, device history record evaluations, and basic failure analysis. The position works closely with cross-functional teams to support quality and regulatory objectives, identify potential adverse events, maintain accurate records, and contribute to continuous improvement initiatives. Success in this role requires strong analytical and organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced, regulated medical device environment. This position is integral to supporting the department through complaint handling, reportability determination, data analysis, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews, review, and closure of certain categories of complaints and work on complaint handling projects. It requires organization and attention to detail while working with other functions within the organization to ensure compliance and accomplishment of tasks.

Responsibilities

• Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.
• Assess complaint vigilance reportability for moderate risk complaints, utilizing system based decision trees
• Perform data entry and prepare reports / graphs related to special projects, complaints and lot qualification.
• Maintain accurate documentation and files related to special projects, complaints and lot qualification.
• Review and analyze lot documentation (DHR’s) to determine if there are any anomalies that may have related to reported product failures.
• Process feedback letters and communicate to product support managers for various reporting sites.
• Perform basic product review and failure analysis.
• Support investigation and review of potential adverse events.
• Support database development and reporting capabilities related to the complaint / reliability department needs.
• Assist in gathering information and data during FDA, ISO or other third party or internal audits, as requested.
• Responsible for leading projects aimed at the continuous improvement of the complaint handling function.
• Performs other duties as required.

Education and Experience/ Minimum Requirements

• High school diploma or technical or scientific discipline; and/or equivalent combination of education and experience.
• Complaint handling experience preferred
• Minimum of 1-2 years’ experience in data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.

Preferred Skills and Competencies

• Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.
• Ability to organize and judge priorities.
• Excels at generating and maintaining organized and accurate records.
• PC skill, word processing, spreadsheet, database.
• Able to work effectively in a high-stress, high-energy environment.
• Able to make decisions quickly based on vague or imperfect information and evaluate the need to obtain clarification and direction when necessary.

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. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights) Insulet employees are all focused on the same goal - to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers - leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.