Team Lead, Receiving & Inspection

Position Overview:

The Team Lead, Receiving & Inspection plays a critical role within Insulet’s Quality Department, serving as a hands-on leader responsible for managing the receipt, initial visual inspection, and handling of returned FDA-approved medical devices. This role requires strong organizational skills, attention to detail, and the ability to work cross-functionally to support departmental and company objectives. The Team Lead ensures compliance with regulatory standards, drives operational efficiency, and supports product returns and continuous improvement initiatives.

Responsibilities:

• Lead the Post Market Receiving & Inspection team in managing return sample intake, handling, and documentation.

• Track and report daily team metrics to ensure performance targets are met.

• Maintain relationships with device return distributors and external partners.

• Coordinate and monitor global device returns through reverse logistics pathways.

• Provide mentorship and work leadership to team members, including training on processes and procedures.

• Ensure compliance with quality and safety standards across all receiving and inspection activities.

• Implement and maintain effective processes to support operational excellence.

• Develop and update protocols and standards to meet quality specifications; recommend procedural improvements.

• Review Device History Records (DHRs), Nonconforming Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs), and deviations related to individual complaints.

• Manage, facilitate, and participate in continuous improvement projects.

• Review and sign off on work completed by receiving and initial inspection team members.

• Coordinate cross-functional projects related to product returns or product handling.

• Perform other duties as assigned.

Education and Experience:

Minimum Requirements:

• BS/BA degree, preferably in a technical discipline (Business, Operations, Engineering, or Science), or equivalent experience

Preferred Qualifications:

• Supervisory experience, preferably in an ISO 9001, ISO 13485, and/or FDA-regulated environment.

• Experience working with medical device quality system requirements (21 CFR Part 820, ISO 13485).

• Proven leadership skills with the ability to engage, coach, mentor, and develop team members.

• General knowledge of performance metrics and operational reporting.

• Effective verbal communication and technical writing skills.

• Demonstrated ability to organize, prioritize, and follow through on multiple tasks with minimal supervision.

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!

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