Senior Quality Assurance Engineer

6 days ago


Marlborough, Massachusetts, United States Boston Scientific Full time

About the Role:

The Senior Supplier Quality Engineer will be responsible for ensuring that suppliers of finished devices meet Boston Scientific's quality standards. This role requires a primary commitment to patient safety and collaboration with cross-functional internal/external resources to improve supplier manufacturing processes.

Key Responsibilities:

  • Evaluate and communicate quality issues to suppliers, applying systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
  • Assess supplier capabilities through on-site visits and technical discussions, coordinating evaluation of proposed changes at suppliers.
  • Plan and lead supplier audits to assess compliance with regulatory standards and Boston Scientific requirements.
  • Manage sustaining quality issues, process change impacts, and design change implementations for suppliers within the Acquired Entity Quality system.
  • Investigate and solve non-conformances due to incoming inspection at BSC Distribution Centers.
  • Support Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
  • Investigate complaints and manage NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related.
  • Support Supplier Change Impact Assessments for process changes at suppliers.
  • Lead projects and consistently hit project milestones, creating crisp and clear project plans and developing strong contingency plans as part of the project planning process.

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