Sr Supplier Qual Engineer Top 3 Must-HavesPPAP / 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.
