Summary :
We are seeking an experienced Supplier Quality Engineer (SQE) with a strong background in the Medical Device industry to support supplier quality, compliance, and process validation activities.
Roles & Responsibilities :
Ensure suppliers consistently deliver quality parts, materials, and services meeting company requirements
Evaluate and onboard suppliers into the Approved Supplier List (ASL)
Review and approve PPAP documentation, Control Plans, Process Flow Charts, Capability Studies, DFMEA, and PFMEA
Conduct supplier risk assessments and maintain supplier risk profiles
Facilitate Supplier Quality Agreements and conduct supplier audits
Support Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans
Coordinate supplier evaluation and selection activities for new suppliers and process changes
Manage documentation within PLM systems and ensure timely approvals and releases
Collaborate with global quality teams on Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiatives
Education & Experience :
Bachelor's degree in Engineering, Technical, or Scientific discipline
8+ years of Supplier Quality experience in the Medical Device industry Strong knowledge of quality systems, supplier quality processes, and regulatory requirements
Experience with PPAP, DFMEA, PFMEA, MSA, Risk Management, and Process Validation (IQ/OQ/PQ)
Experience working with PLM systems and quality documentation tools
Numbers & Facts
Location
Salt Lake City, UT
Skills
Auditingunmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Document Managementunmatched
Documentationunmatched
Documentation Planunmatched
Medical Equipmentunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Flowunmatched
Process Validationunmatched
Product Lifecycle Managementunmatched
Production Part Approval Process (PPAP)unmatched
Quality Engineeringunmatched
Regulatory Requirementsunmatched
Riskunmatched
Risk Analysisunmatched
Risk Managementunmatched
Software Testingunmatched
Systems Administration/Managementunmatched
Time Managementunmatched
Vendor/Supplier Evaluationunmatched
Vendor/Supplier Selectionunmatched
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