AL
Sr Supplier Qual Engineer
Artech LLC
🇺🇸 United States
On-site
Senior
4 days ago
- PFMEA
- Risk Management
- SPC
4 days ago
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; establishacceptance sampling plans.
- Medical Device Quality: Experience withmedical-device quality systems and regulated manufacturing; Client quality system experience preferred.
Key Responsibilities
- Qualify and manage suppliers forNPI/NPD and production parts.
- ManagePPAP deliverables, including Control Plans, PFMEA, IQ/OQ/PQ, process capability and FAI.
- Support and maintainApproved Supplier List (ASL), supplier selection, segmentation, agreements and audits.
- Develop/validateinspection and test methods with suppliers, Incoming Inspection and Metrology.
- Establishacceptance sampling plans and inspection requirements.
- Review/approveengineering/change orders affecting suppliers or parts.
- Investigate and dispositionnon-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.
- StrongSupplier 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.
Sr Supplier Qual Engineer · Artech LLC