Technical Lead

Responsibilities:Ensure that suppliers deliver quality parts, materials, and services.Qualify suppliers according to company standards.Review and approve the documents required to qualify through the PPAP process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)).Supplier risk segmentation.Supplier Quality Agreements.Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes.Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan.Route PPAP Checklist in Agile.Leverage GMP (Good Manufacturing Practices). Navigate the complexities of various industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971.Requirements:Measurement System Analysis / Test method Validation.PPAP experience.Supplier document review and approval per MDT process.Supplier control and management.Work closely with suppliers.Mini tap experience.Critical component identification and qualification.Perform receiving inspection.Driving supplier activities.Leadership toward supplier activities and interaction.

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