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.

Key Responsibilities

• 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.

Qualifications

• 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.

Preferred Skills

• 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.

Additional Information

• This position is based at our Acton, MA site.
• Estimated travel: 10-15%, with flexibility based on business needs.
• Expect 5–10% overlap with global manufacturing sites across various time zones.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
Additional Information:
The US base salary range for this full-time position is $84,900.00 - $127,350.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
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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• 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