Quality Analyst, Lot Release (Onsite - Acton, MA)

The Lot Release Coordinator is responsible for ensuring timely and compliant product lot release by actively reviewing, tracking, and driving closure of open quality-related action items. This role serves as a central coordination point across Quality, Manufacturing, and Engineering to ensure all quality events—such as NCMRs, rework, sorting, and development activities—are appropriately addressed prior to lot disposition.

 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. We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Overview The Lot Release Coordinator is responsible for ensuring timely and compliant product lot release by actively reviewing, tracking, and driving closure of open quality-related action items. This role serves as a central coordination point across Quality, Manufacturing, and Engineering to ensure all quality events—such as NCMRs, rework, sorting, and development activities—are appropriately addressed prior to lot disposition. The position requires strong organizational skills, attention to detail, and the ability to proactively follow up on cross-functional dependencies to prevent delays in release. Responsibilities  •    Review production lots for release readiness, ensuring all required quality documentation and activities are complete. •    Identify and assess any open quality action items tied to lots (e.g., NCMRs, rework, sort activities, deviations). •    Partner with Quality Engineering and Manufacturing to determine disposition status and readiness. •    Maintain a centralized tracker of open quality events impacting lot release. •    Monitor status of: Nonconforming Material Reports (NCMRs), Rework and Sort activities including containment, Development or validation activities, and other quality-related holds •    Ensure accurate and up-to-date visibility of lot status across systems (e.g., SAP, Arena, others). •    Proactively follow up with responsible owners (Quality, Operations, Engineering) to drive timely closure of action items. •    Identify bottlenecks and escalate risks to leadership when timelines are at risk. •    Facilitate cross-functional alignment to resolve blockers impacting lot release. •    Provide regular status updates on lot release readiness and open quality issues.  •    Maintain and translate large datasets (e.g., spreadsheets, trackers) into clear, concise, and actionable insights.  •    Develop executive-level presentation materials (e.g., slide decks) summarizing lot status, risks, and key quality metrics.  •    Prepare and present content for leadership forums, including VP and SVP-level reviews.  •    Clearly communicate risks, priorities, trends, and recovery plans in a format tailored for senior leadership decision-making. •    Ensure all activities comply with internal quality systems, procedures, and regulatory requirements. •    Support audits by maintaining traceability of decisions and actions impacting lot release. •    Identify process gaps and recommend improvements to streamline lot release processes.

Competencies •    Strong organizational