The Quality Engineer (QE) is accountable to ensure that activities in the focus factory are conducted effectively and in adherence to Standards Operating Procedures (SOPs) of both, site and corporate level. Provides support to manufacturing and incoming inspection areas, aiding to ensure product with the highest quality is delivered to our customers. The QE regularly monitor the production process and equipment’s to ensure the KPIV/KPOVs are being met, including packaging process. The QE collects relevant data from the various related sources to track trend, analyze using applicable statistical tools, to proactively address opportunities for reducing/preventing NCRs, CAPA Investigations and Complaints (FTRs). The QE also works in collaboration with the Manufacturing Engineer for improving the quality of the process and/or equipment performance. Ensure that products and/or process issues
|Requisitos - Requirements
• Provides support and supervise process activities to ensure process/product stability, parts are procured and products manufactured in accordance with customer and company requirements in adherence with worldwide quality systems regulations and/or normative for devices.
• Responsible for the effective implementation of testing standards and sampling plans used for quality checks, including inspection techniques.
• Support product transfers process and/or equipment/computerized system acquisitions.
• Supports implementation of Statistical Process Controls (SPC) Techniques on the manufacturing process to achieve higher standards of quality and cost reduction.
• When needed, identify the application of Process Excellence tools to solve process/product related problems.
• Support investigations (NCRs, CAPAs & FTRs) on issues performed by Manufacturing Engineers