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

Position Overview

Insulet Corporation, founded in 2000, is committed to ing 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.

Role Summary

The Sr. Supplier Quality Engineer plays a key role in ensuring that materials, components, and services provided by suppliers meet Insulet’s quality and regulatory standards for medical devices. This individual will be part of the Supplier Quality Engineering team providing support to Electronics, Plastics and Metals commodity teams, and support quality systems improvement efforts. This role will support both new product development and ongoing production. He/She will represent the voice of the customer to our supply chain partners and is a continuous quality improvement force within the organization through effective interactions within the broader Manufacturing, Quality and Supply Chain teams and cross collaboration with NPI, Design Engineering, Supplier Development Engineering, Procurement, and Product Management.

Key Responsibilities

• Partner with suppliers and internal teams to ensure raw materials and components meet specifications and quality requirements.
• Communicate design and inspection changes to suppliers, ensuring alignment with internal procedures.
• Work with New Product Development team on development of next-generation device platform
• Support supplier onboarding for new product components, ensuring timely evaluations and approvals aligned with product launch timelines.
• Lead and support supplier-driven quality improvement initiatives, including root cause analysis and corrective actions.
• Develop, maintain, and update supplier quality documentation and systems.
• Implement ongoing monitoring of supplier process controls, including process capability on critical to quality features.
• Execute Product Part Approval Process (PPAP) steps to build quality early in the product life cycle to qualify parts into production.
• Monitor supplier performance using scorecards and metrics (e.g., DPPM, CAPA, audits, certifications, FMEAs).
• Participate in internal and external audits, including root cause analysis and CAPA implementation.
• Review and approve material/component documentation and qualification protocols.
• Contribute to risk management activities and ensure compliance with applicable standards and regulations.
• Partner with early-stage R&D teams to support supplier selection, and quality inspections for new product development
• Perform other duties as assigned.
  
  

Qualifications

• Bachelor’s degree in Engineering.
• 5–8 years of experience in Quality Assurance within FDA, ISO, or other regulated environments.
• Solid understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Familiarity with global regulatory requirements.
  
  

Preferred Skills

• Demonstrated ability to build and maintain effective working relationships with external suppliers to ensure alignment on quality standards, timelines, and continuous improvement initiatives.
• Experience working on new product development initiatives.
• Working knowledge of EN 60601 and ISO 62304.
• 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 with an
  
  

expected on-site presence of four days a week.

• Estimated travel: ~5%, with flexibility based on business needs
  
  

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.

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 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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