Senior Supplier Quality Engineer (Onsite - Acton, MA)

Job Summary





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:



Compensation & Benefits:

For U.S.-based positions only, the annual base salary range for this role is $87,100.00 - $130,600.00

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.