About the Role
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 (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. Responsibilities: Maintain company compliance and continuous improvement of the QMS to ISO 13485, MDSAP, EUMDR, FDA QMSR, and other applicable standards/regulations. Assist in the development, implementation and maintenance of the quality system and its procedures, including review against applicable standards/regulations. Track, monitor, and report on quality objectives, supporting follow-up on improvement actions and helping identify trends for continuous improvement. Create & manage Power BI (or equivalent) dashboards to provide weekly and monthly KPI reporting and assist in developing predictive analytics and forecasting models to generate useful insights. Drive nonconforming material report (NCMR) and/or Process Change Order Assessment (PCOA) and improve those process efficiency as necessary. Drive implementation of improvement actions by identifying opportunities to enhance efficiency, monitoring risks, and contributing to initiatives that deliver measurable results. Ensure validation documents complies to Good Documentation Practices (GDP), ensuring accuracy, completeness, and compliance with internal and regulatory requirements. Performs other duties as required. Minimum Requirements: Bachelor’s degree in science/engineering/computer systems/project management or quality management curriculum and/or equivalent combination of education and experience. Advanced knowledge of Microsoft Office programs (e.g. Word, Excel and PowerPoint). Experience in building and managing dashboards (i.e. Power BI, Spotfire, and etc.) Preferred Skills and Competencies: 2-3 years’ work experience in a regulated industry, preferably medical devices. Knowledge of the Quality Management System Regulation (FDA 21 CFR Part 820) and/or ISO 13485 quality system standards with experience in Health Authority inspections. Possess excellent communication (both verbal and written), leadership, and interpersonal skills. Critical thinking and problem-solving skills, with high attention to detail. Ability to multitask and be able to contribute positively as an individual and as a team player. 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.