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.
Key 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.
Required Qualifications:
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, 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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