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DescripciónDescription
Principal Duties and Responsibilities:
• Performs testing and/or inspection of raw materials, components, in-process sub-assemblies, and final products as specified on drawings and/or procedures. Retrieves device history records (DHR) when required.
• Performs environmental and water system sampling.
• Monitors process to be in accordance with procedures.
• Audits procedures
• Identifies discrepancies and documents in a nonconformance report. Performs quarantine of nonconforming material.
• Monitors for GMP/QSR & ISO compliance on the assigned area and reports the nature of violation writing to immediate supervisors.
• Certifies training of product related operations to assure they perform as per procedures and drawings.
• Other tasks assigned by Quality Supervisor and/or upper management.
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Requisitos Requirements
• Associate degree in science related discipline or equivalent.
• At least 1 year of quality related tasks and/or quality control/assurance experience.
• Knowledge of medical devices GMP/QSR & ISO regulation and application.
• Computer literate (Word, Excel, Power Point, Outlook, etc.).
• Bilingual (English and Spanish).
• Basic knowledge on Root Cause Analysis tools (fishbone, etc.).
• Knowledge in the use of mechanical and electrical measuring devices (calipers, plug gage, thread gage, depth gage, micrometer, multi-meter, LCR digi-bridge meter, oscilloscopes, etc.).
• Knowledge on drawings reading and interpretation.
• Knowledge on quality sampling size calculations.
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