Quality Assurance Engineer

hace 2 semanas


Ciudad Juárez, México BD A tiempo completo

**Job Description Summary**: To develop and document Quality plans and procedures as required. Prevent and resolve Quality problems. Improve areas of high-quality costs. Represent quality interests and concerns on project teams. Conduct root cause analysis and investigation for customer complaints and non-conformance product. Ensure compliance with Corporate, ISO, FDA, and Local standards requirements.**Responsibilities**:- Provide technical support to resolve quality problems in development, pilot, manufacturing- Design and conduct quality engineering studies to determine causes of quality nonconformances, initiate changes in process, tooling, etc., to correct them.- Organize and generate detailed quality information reports to engineering, manufacturing, and management.- Provide documented instructions for performance of QC inspections, including QC plans, inspection and test procedures, and quality Standards.- Exercise control over the quality of conformance of the products generated in his area\Design and qualify inspection and test equipment.- Lead and guide peers and direct-reporting personnel, on how to conduct the Nonconformance process (NC).- Development of Test Methods.- Development of Control Plans.- Approve/support validations protocols (Software/IQs/OPs/PQs) if applicable.**Education**- Bachelor’s degree in technical sciences or Engineering.**Knowledge & Skills**- Minimum 1year experience in Quality/Manufacturing or Engineering positions.- Knowledge on International Regulations and Standards (i.e., ISO-13485, FDA, etc.).- Knowledge on Quality Tools and statistical techniques. (Control charts, sampling plans, Design of experiments, etc.).- Knowledge on Quality systems.- Communication, Reports, Data analysis.- Root cause analysis techniques.- Ability to communicate in English (Oral and written) fluently.**Required Skills**:Optional Skills**Primary Work Location**: MEX Juarez Healthcare**Additional Locations**:**Work Shift**:



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