Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives using 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! This Sr. Quality Manager is responsible for ensuring quality system compliance within the Production and Process sub-process for governance and governance of related quality systems. The Sr. Quality Manager. Process Excellence will partner with “process owners” to identify best practices, harmonize where appropriate (and where not to) and implement improvements to be documented into Policies, Procedures, and Work instructions that define how Insulet manages the supply chain within “Production and Process Controls” to include: Work Environments Calibration and Equipment Controls Microbiology and Sterilization Process Controls Process Validation Acceptance Activities Identification and Traceability Product Storage Handling, & Distribution Controls Servicing This effort requires a broad skill set for facilitation, communication, and understanding of various Int’l regulations and standards to improve the quality management system. Effectively communicating quality system, requirements, optimizing development. Also, review and ensuring ambiguities and conflicting requirements are resolved is critical to the success of the position.