Senior Supplier Quality Engineer; Onsite - Acton, MA

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 lead a team of Supplier Quality Engineers focused on driving Electronics commodity excellence. This position works closely with external suppliers in collaboration with internal cross-functional teams, including Supplier Development, R&D, Mfg.

Engineering, Procurement, Regulatory Affairs, and Operations. Other significant impacts will come from collaborating on the selection and qualification of capable suppliers, leading the efforts to quantify and improve supplier performance, and providing a positive impact on the quality of products through a global footprint.

• Inspire and lead a team of Supplier Quality Engineers for day-to-day quality issues. Coach and mentor team members on various supplier-related and internal Quality System issues
• Engage in selection and evaluation activities of new potential suppliers, auditing the first tier and critical sub-tier suppliers for their onsite quality, capability, technology and/or process related requirements.
• 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.
• Evaluate supplier inspection processes, provide recommendations and validate supplier’s ability to determine part acceptance.
• Lead and support supplier-driven quality improvement initiatives.
• Develop, maintain, and update supplier quality documentation and systems.
• Monitor supplier performance using scorecards and metrics (e.g., CAPA, audits, certifications, FMEAs).
• Issue and drive Supplier Corrective Action Report (SCAR) to resolve issues. Participate in root cause analysis of supplier caused non-conforming product and ensure product quality concerns are adequately addressed by the supplier. Drive corrective action and continuous improvement activities that directly impact performance for assigned suppliers
• Support remediation efforts for suppliers displaying low quality performance and resolve issues related to nonconforming materials or services.
• Lead monthly quality performance reviews with high defect suppliers to drive defect reduction and report progress.
• Manage Supplier Quality-related risks; develop and implement supplier risk mitigation strategies as appropriate. Serve as the escalation point for critical supplier quality issues, driving resolution and communicating impact to leadership
• Manage Supplier change notification process for supplier quality related activities.
• Maintain accurate supplier records in ERP and PLM systems.
• Participate in internal and external audits, including root cause analysis and CAPA implementation.
• Review and approve material/component documentation and qualification protocols.
• Perform other duties as assigned.

• Bachelor’s degree in Electronics / Electrical / Biomedical Engineering or equivalent education/experience.
• Solid knowledge and expertise in problem solving related to manufacturing processes of PCBAs, PCBs, and electronic sub-assemblies. Strong understanding of SMT, ICT, FCT, and reliability testing.
• 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.

• Ability to analyze supplier performance data and present actionable insights to drive improvement.
• Excellent time management skills and ability to multi-task and methodically manage project milestones.
• Working knowledge of EN 60601 and ISO 62304. Certifications such as ASQ CQE, Six Sigma, or Lead Auditor (ISO 13485) are a plus.
• Strong communication skills and ability to work across multiple levels of the organization.
• Comfortable managing priorities in a dynamic, high-energy environment.

• This position is based at our Acton, MA site.
• Estimated travel: 10-15%, with flexibility based on business needs.
• Expect 5–10%…