Quality Engineer

hace 3 semanas

Tijuana, México AP Services de México, S. de R. L. de C.V. A tiempo completo

Responsibilities QA Engineer I that reports to HQ findings and compliance with healthcare productcheck and recheck data, administration data coming from production batches, analyzing, confirm product is correctly documented and assuring parts are OK in the QA/QC levels at 99% of the job-content. Carry out the review and approval of document changes, including procedures, work instructions, forms, and specifications, ensuring compliance with quality systems and good documentation practices in healthcare production. Monitor and control KPIs related to open MDRs (Material Discrepancy Reports), ensuring their follow-up, timely closure, and proper documentation. Verify that the production, inspection, and test records are complete, accurate, and traceable. Participate in the identification and analysis of non-conformities, supporting corrective and preventive actions (CAPA). Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information. Review Design History Files (DHF) for accuracy and compliance to internal and regulatory (FDA) requirements. Generate statistical reports on quality performance in the process and in the product: Review quality data trending to determine if action(s) need to take place. Execute CAPA (Corrective and Preventive Action) tools as required, to bring about the desired changes and continuous improvement. Qualifications Industrial Engineer or related 2 to 3 years of experience in quality systems. Strong Communication Skills (both written and verbal) Advanced English (MIN 80%) Knowledge of quality systems: ISO 13485 Experience with CAPA, required. Knowledge of methodologies: Lean Manufacturing, APQP, FMEA, SPC Strong knowledge of computer database Excel. Strong aptitude for problem solving root cause analyses. Experience in monitoring non-conformities and corrective actions. #J-18808-Ljbffr

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