Sr. Supplier Quality Engineer, Indirect Purchase Family (Onsite - Acton, MA)

Company Overview 

Insulet Corporation, founded in 2000, is committed to transforming the lives of people with diabetes through its Omnipod® product platform—a wearable, waterproof, and user-friendly insulin delivery system. Over the past two decades, our technology has helped hundreds of thousands of users live simpler, healthier lives. We’re expanding our team and looking for passionate, driven individuals who thrive in a collaborative, fast-paced environment. 

Position Overview

The Senior Supplier Quality Engineer for Indirect Commodity will lead quality oversight and strategic engagement with Insulet’s indirect service suppliers, including software vendors, design houses, testing laboratories, sterilization service providers, and other specialized service entities. This role ensures that all services meet Insulet’s quality, regulatory, and business requirements, and supports cross-functional collaboration across R&D, Procurement, Regulatory Affairs, and Operations.

Key Responsibilities 

• Own and execute the quality strategy for Indirect service suppliers.

• Ensure compliance with ISO standards (e.g., ISO 11137, 11135, 17025, 14644) and FDA regulations for sterilization, testing, and software services.

• Evaluate Indirect suppliers for QMS relevance and define type and extent of control required based on the nature of service provided. Maintain ASL control for these suppliers.

• Lead qualification, onboarding, and periodic evaluation of service suppliers.

• Conduct supplier audits and assessments to verify supplier capabilities and compliance.

• Maintain supplier records in ERP and PLM systems.

• Develop and review quality agreements, validation protocols (IQ/OQ/PQ), and risk assessments (pFMEA, Control Plans etc.).

• Support CAPA investigations and nonconformance resolution.

• Partner with Procurement and Supplier Development teams to align supplier selection with business needs.

• Communicate inspection and process changes to suppliers and internal stakeholders.

• Monitor supplier performance using scorecards and KPIs.

• Drive supplier-led quality improvement initiatives.

• Provide technical guidance on sterilization, software validation, and lab testing protocols.

• Support internal and external audits and regulatory inspections.

 

Qualifications 

• Bachelor’s degree in Engineering.

• 5–8 years of experience in Quality within FDA, ISO, or other regulated environments.

• Solid understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.

Preferred Skills 

• Strong communication skills and ability to work across multiple levels of the organization. 

• Comfortable managing priorities in a dynamic, high-energy environment. 

 Additional Information 

• This position is based at our Acton, MA site. 

• NOTE: This position requires on-site working, at least 4 days a week.

• Estimated travel: 10-15%, with flexibility based on business needs. 

  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 $85,125.00 - $127,687.50 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 fingerstic