Insulet Corporation-posted 3 months ago
$84,900 - $127,350/Yr
Full-time • Mid Level
Acton, MA
Miscellaneous Manufacturing

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.
  • Base salary range of $84,900.00 - $127,350.00.
  • Salary determined by role, level, and location.
  • Compensation details reflect base salary only, excluding bonus, equity, or benefits.
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