This position is responsible for maintaining and improving supplier quality through supplier validation, technical troubleshooting, execution, training, and other supplier quality
engineering activities.
Essential Duties and Responsibilities
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Collaboration and coordination with the purchasing, production and engineering departments in relation to the quality of the suppliers.
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Management of SCNs/SCRs to avoid line-down situation and follow-up and closure of changes required by suppliers (SCRs).
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Perform process validation such as IQ, OQ & PQ. PPAP experience preferred.
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Act as an Technical SME for processes such as Injection Molding, Blow Molding, Compression/Transfer Molding, Extrusion.
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Maintenance of supplier records (ASL, SCAR).
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Maintenance and improvements to the supplier quality metrics process
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Qualification of raw materials through the Quality Assessment System (AQA)/PPAP
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Opening, monitoring, investigation, effectiveness review and closure of Corrective Actions required of suppliers (SCARs)
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Up to 25% travel needed.
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Know and apply the policies and procedures of the ISO 13485, 21 CFR part 820 Quality Systems and any other system that the company requires for its operation.