✦ Luna Orbit — Legal & Compliance

Supplier Quality Engineer II - External Operations (SFMD)

at Boston Scientific

📍 Arden Hills, MN, US, 55112 Unknown Posted March 18, 2026
Type Not Specified
Experience mid
Exp. Years 3+ years
Education Not specified
Category Legal & Compliance

Boston Scientific seeks a Supplier Quality Engineer II to oversee supplier quality issues, conduct audits, and support regulatory compliance for Sourced Finished Medical Devices, ensuring product safety and quality.

  • Evaluate and resolve supplier quality issues
  • Review and approve corrective action plans
  • Conduct supplier audits
  • Support design validation activities
  • Investigate nonconformances

The role involves evaluating supplier manufacturing capabilities, managing quality issues, supporting design validation, and conducting supplier audits, with tools like SAP and Jira.

The ideal candidate is a mid-level supplier quality engineer with 3+ years of experience in medical device manufacturing, skilled in supplier audits, corrective actions, and regulatory compliance, with strong analytical and communication skills.

experience in supplier quality engineeringability to evaluate and resolve quality issuessupport for supplier audits
experience with medical devicesregulatory knowledgeproduct validation
SAPJiraMicrosoft Office Suite
Supplier QualityCorrective Action PlansSupplier AuditsRegulatory ComplianceProduct QualityNonconformance InvestigationQuality SystemsDesign ValidationManufacturing Processes
Supplier QualityCorrective Action PlansSupplier AuditsRegulatory ComplianceProduct QualityNonconformance InvestigationQuality SystemsDesign ValidationManufacturing Processes
problem-solvingcommunicationcollaborationanalytical thinkingattention to detail
Industry Medical Devices / Healthcare
Job Function Manage supplier quality and compliance for medical device manufacturing
Role Subtype Supply Chain & Procurement
Tech Domains SAP, Jira, Microsoft Office Suite
Clearance Required None
Visa Sponsorship No
supplier quality engineersupplier auditscorrective action plansregulatory compliancemedical devicesnonconformance investigationproduct qualityquality systemssupplier oversightdesign validationrisk mitigationincoming inspectionfield actionsmanufacturing processesquality issues

Lack of experience in supplier quality, No background in medical devices, Inability to perform supplier audits

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