Company Overview
Insulet started in 2000 driven to achieve our mission of enabling 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 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
This role plays a strategic part in strengthening Insulet’s reputation for quality and reliability, ensuring customer satisfaction and fostering long-term partnerships. As a critical interface between Insulet’s B2B customers and internal quality teams, this role ensures that all customer feedback is managed in alignment with our Quality Management System (QMS) and that a closed loop process is well executed. The successful candidate will play a major role in defining and executing complaint handling, corrective actions, and regulatory documentation processes between Insulet and these external entities—reinforcing our commitment to safety, compliance, and continuous improvement in the medical device industry.
Responsibilities
Act as the primary Quality contact between Insulet and external B2B customers.
Ensure appropriate intake, investigation, documentation, and escalation of B2B customer complaints, nonconformances, deviations, and product quality feedback.
Actively manage and resolve B2B customer escalations related to product quality, ensuring timely and effective communication and resolution.
Collaborate cross-functionally with B2B Customer Project Teams, Quality Assurance, Regulatory Affairs, Supplier Quality, and Engineering to resolve product issues.
Coordinate B2B customer approvals for design and manufacturing changes impacting devices.
Review and evaluate change notifications, ensuring timely support to B2B customer impact assessments and alignment with quality and regulatory requirements.
Contribute to risk assessments and mitigation strategies for B2B customer-facing quality issues and product changes.
Drive timely follow-up and closure of B2B customer-related CAPAs by working with global manufacturing sites, internal teams, and external suppliers.
Maintain complaint files in compliance with internal procedures and external regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
Support internal and external audits with accurate records and summaries of complaint handling activities.
Lead or support internal projects involving B2B customer-specific devices.
Capture and integrate Voice of Customer insights into quality processes and product lifecycle improvements.
Develop and maintain processes for B2B customer-impacted change management and investigations.
Analyze complaint data to identify trends and contribute to quality improvement initiatives.
Support the development and maintenance of quality agreements with B2B customers ensuring alignment with regulatory and business requirements.
Ensure all communications adhere to company policies, regulatory standards, and ethical practices.
Schedule, prep, and lead periodic Quality reviews with B2B customers.
Other duties as assigned.
Required Leadership/Interpersonal Skills & Behaviors
Demonstrates agility and responsiveness to evolving B2B customer needs and quality challenges.
Effectively influences cross-functional teams and B2B partners to drive resolution and improvements.
Demonstrates a strong customer-centric mindset, advocating for B2B customer needs.
Builds strong cross-functional partnerships across Engineering, Operations, and Account Management.
Communicates clearly, concisely, and persuasively across all organizational levels.
Possess exceptional skill in handling competing priorities and requirements, especially with external entities.
Adept at driving consensus and action, culminating in clear communication.
Required Skills and Competencies
Strong understanding of QMS systems, complaint handling, and regulatory frameworks.
Exceptional organizational skills and attention to detail.
Excellent written and verbal communication abilities.
Professional handling of confidential and sensitive information.
Proficiency in analyzing quality data and generating actionable insights through dashboards or reports.
Education and Experience
Bachelor’s degree in Engineering, Life Sciences, or a related field.
Minimum of 5 years of experience in medical device customer service or quality support.
Additional Information
This position is based at our Acton, MA site.
Estimated travel: ~5%, with flexibility based on business needs.
Expect 5–10% overlap with global manufacturing sites across various time zones.
NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid
Additional Information:
Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $89,850.00 - $134,775.00 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.