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

Insulet Corporation-posted about 2 months ago
Full-time • Mid Level
Onsite • Acton, MA
5,001-10,000 employees
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The Senior Supplier Quality Engineer for Indirect Commodity will lead quality oversight and strategic engagement with Insulet's indirect service suppliers, including software vendors, design houses, testing laboratories, sterilization service providers, and other specialized service entities. This role ensures that all services meet Insulet's quality, regulatory, and business requirements, and supports cross-functional collaboration across R D, Procurement, Regulatory Affairs, and Operations.

  • Own and execute the quality strategy for Indirect service suppliers.
  • Ensure compliance with ISO standards (e.g., ISO 11137, 11135, 17025, 14644) and FDA regulations for sterilization, testing, and software services.
  • Evaluate Indirect suppliers for QMS relevance and define type and extent of control required based on the nature of service provided.
  • Maintain ASL control for these suppliers.
  • Lead qualification, onboarding, and periodic evaluation of service suppliers.
  • Conduct supplier audits and assessments to verify supplier capabilities and compliance.
  • Maintain supplier records in ERP and PLM systems.
  • Develop and review quality agreements, validation protocols (IQ/OQ/PQ), and risk assessments (pFMEA, Control Plans etc.).
  • Support CAPA investigations and nonconformance resolution.
  • Partner with Procurement and Supplier Development teams to align supplier selection with business needs.
  • Communicate inspection and process changes to suppliers and internal stakeholders.
  • Monitor supplier performance using scorecards and KPIs.
  • Drive supplier-led quality improvement initiatives.
  • Provide technical guidance on sterilization, software validation, and lab testing protocols.
  • Support internal and external audits and regulatory inspections.
  • Bachelor's degree in Engineering.
  • 5-8 years of experience in Quality within FDA, ISO, or other regulated environments.
  • Solid understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Strong communication skills and ability to work across multiple levels of the organization.
  • Comfortable managing priorities in a dynamic, high-energy environment.
  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO)
  • And additional employee wellness programs
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