[ES635] | Ingeniero De Calidad Sr

[ES635] | Ingeniero De Calidad Sr

18 ene
|
ICU Medical Tijuana
|
Baja California

18 ene

ICU Medical Tijuana

Baja California

Position Responsibilities:Develop and implement Incoming Inspection processes for parts.Develop and collaborate with Manufacturing and R&D; on in-process Test Methods and Test Methods Validation (TMV).Disposition on subassembly and component level drawing changes.Identify Critical to Quality dimensional tolerances for inspection.Inspect inventory for any reported conformance issues.Prepare First article inspection reports.Disposition decision on supplier and associated manufacturing process changes.Manage NCMR and CAPA while leading cross-functional teams to drive root causes and final resolution.Lead cross-functional quality improvements.Minimum Requirements:Manufacturing process knowledge of general assembly for either electro-mechanical,



electronics, and/or mechanical assembly.Process knowledge of machining, molding, and tool designs.Medical devices patient risk management process knowledge.Experience working in medical devices regulatory compliance industry.Strong verbal and written communication and technical writing skills.Problem solving basic statistics skills; knowledge of Lean sigmaprinciples is preferred.Proven abilities to multi-task while being organized.Good interpersonal skills to collaborate with cross-functional roles.Minitab for statistical data analysis.Gage R&R; and DOE knowledge.Engineering Degree / Sr. Level.#J-18808-Ljbffr

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