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

Insulet Corporation•Acton, MA

55d•$85,125 - $127,688•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.

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.