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

Job Summary

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.

Position 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.

Required Skills Competencies

• Strong organizational and tracking skills with high attention to detail.
• Ability to manage multiple priorities in a fast-paced environment.
• Proven ability to collaborate cross-functionally and influence without direct authority.
• Strong written and verbal communication skills (especially for leadership updates).
• Experience with ERP systems (e.g., SAP) and quality tracking tools.
• Proactive ownership mindset - drives closure, not just tracking
• Assertive but collaborative - able to push for timelines while maintaining strong relationships
• Data-driven - uses metrics and tracking to manage performance
• Detail-oriented - ensures no gaps in release readiness
• Resilient under pressure - handles competing priorities and urgent demands effectively

Education and Experience

• Bachelor's degree
• Five (5+) years of experience working in Quality in a manufacturing environment

Physical Requirements

• Ability to lift up to 30 lbs.
• Frequently standing, walking, reaching above shoulders and below waist.

Additional Information

• The position is working on-site at our Acton, MA location.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

Compensation & Benefits:

For U.S.-based positions only, the annual base salary range for this role is $73,800.00 - $110,700.00

This position may also be eligible for incentive compensation.

We offer a comprehensive benefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs

Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online.

Actual pay depends on skills, experience, and education.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

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!

At Insulet Corporation 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.

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