Job Description
Job Title: Sr Supplier Qual Engineer
Job ID: 28285
Location: 4620 N Beach St Fort Worth Texas 76137
Duration:12 months
Top 3 Must-Haves
- PPAP / Part Qualification: Control Plans, PFMEA, Risk Management, IQ/OQ/PQ, Process Capability, First Article Inspection (FAI).
- Inspection & Metrology: Develop inspection methods with suppliers/incoming inspection/metrology; validate test methods; establish acceptance sampling plans.
- Medical Device Quality: Experience with medical-device quality systems and regulated manufacturing; Client quality system experience preferred.
Key Responsibilities
- Qualify and manage suppliers for NPI/NPD and production parts.
- Manage PPAP deliverables, including Control Plans, PFMEA, IQ/OQ/PQ, process capability and FAI.
- Support and maintain Approved Supplier List (ASL), supplier selection, segmentation, agreements and audits.
- Develop/validate inspection and test methods with suppliers, Incoming Inspection and Metrology.
- Establish acceptance sampling plans and inspection requirements.
- Review/approve engineering/change orders affecting suppliers or parts.
- Investigate and disposition non-conforming material (NCM).
- Resolve supplier quality issues and drive corrective actions/improvements.
- Evaluate supplier processes/performance and provide feedback.
- Lead or support SQE projects and provide guidance/coaching to junior team members.
Required Qualifications
- Bachelor’s degree + 4+ years relevant experience, OR advanced degree + 2+ years.
- Strong Supplier Quality Engineering experience.
- Medical-device/regulated manufacturing quality experience.
- Strong knowledge of:
- PPAP
- Control Plans
- PFMEA / Risk Management
- IQ/OQ/PQ
- Process Capability / SPC
- FAI
- Inspection & Test Method Validation
- Metrology
- Acceptance Sampling
- Supplier Qualification/NPI
- NCR/NCM and supplier corrective actions
- Change Orders
- Strong communication, problem solving and cross-functional/vendor management skills.
- Onsite Fort Worth availability strongly preferred.
Skills
Change Requests/Ordersunmatched
Coachingunmatched
Communication Skillsunmatched
Corrective Actionunmatched
Cross-Functionalunmatched
Delivery Managementunmatched
Engineeringunmatched
Engineering Change Orderunmatched
Healthcare Qualityunmatched
Manufacturingunmatched
Manufacturing Systemsunmatched
Medical Equipmentunmatched
Metrologyunmatched
People Managementunmatched
Problem Solving Skillsunmatched
Process Capabilityunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Validationunmatched
Product/Service Launchunmatched
Production Part Approval Process (PPAP)unmatched
Quality Assurance Methodologyunmatched
Quality Engineeringunmatched
Risk Managementunmatched
Sampling Inspectionunmatched
Software Testingunmatched
Validation Testingunmatched
Vendor/Supplier Evaluationunmatched
Vendor/Supplier Managementunmatched
Vendor/Supplier Planningunmatched
Vendor/Supplier Selectionunmatched
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