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Technician II
Juncos, PR*Quality Technician**
• Conducts investigation of quality issues and documents as per established policy. Assures product containment within available systems.
• Gathers information for the quality engineers, in order to address product issues
• Performs analysis using lean sigma tools as part of quality issue investigations.
• Assists in the development of training and working standards including, but not limited to, visuals, pictorials, or other mechanisms.
• Assists Quality Engineering in the development / implementation of procedures, work instructions or forms, as required.
• Performs quality audits to the manufacturing line and rearrange schedule based on trending.
• Provides direct support to the production line and operators related to quality issues.
• Provides adequate tools and equipment to ease device inspection.
• Present data or explains situations affecting quality to manufacturing personnel when required.
• Prepares material and data to be presented in quality review meetings.
• Works and implement special projects when required including but not limited to CAPA, Continuous improvement projects, etc.
• Evaluates product/material discrepancies (PRB/MRB), and implement corrective actions on a timely manner
• Performs qualifications / validations for product/processes and equipment, as required.
• Assess adequacy of process inspection points based on process FMEAs.
• Supports product transfers and new implementations.
• Assists in the investigations of quality issues and non-conforming situations as required.
• Prepares and presents trend data pertaining to the calibration area during monthly Quality Review meetings.
• Assists in gathering of information during FDA inspections, Notified Body Audits, Corporate Audits, etc.
• Perform other position duties as assigned.
• Support manufacturing course/certification in the applicable LMS System.
• Support on-the-job training plan to assure personnel compliance.
• Works with document changes in the applicable system (ex. change of manufacturing / quality document changes in Agile)
• Conducts investigation of quality issues and documents as per established policy. Assures product containment within available systems.
• Gathers information for the quality engineers, in order to address product issues
• Performs analysis using lean sigma tools as part of quality issue investigations.
• Assists in the development of training and working standards including, but not limited to, visuals, pictorials, or other mechanisms.
• Assists Quality Engineering in the development / implementation of procedures, work instructions or forms, as required.
• Performs quality audits to the manufacturing line and rearrange schedule based on trending.
• Provides direct support to the production line and operators related to quality issues.
• Provides adequate tools and equipment to ease device inspection.
• Present data or explains situations affecting quality to manufacturing personnel when required.
• Prepares material and data to be presented in quality review meetings.
• Works and implement special projects when required including but not limited to CAPA, Continuous improvement projects, etc.
• Evaluates product/material discrepancies (PRB/MRB), and implement corrective actions on a timely manner
• Performs qualifications / validations for product/processes and equipment, as required.
• Assess adequacy of process inspection points based on process FMEAs.
• Supports product transfers and new implementations.
• Assists in the investigations of quality issues and non-conforming situations as required.
• Prepares and presents trend data pertaining to the calibration area during monthly Quality Review meetings.
• Assists in gathering of information during FDA inspections, Notified Body Audits, Corporate Audits, etc.
• Perform other position duties as assigned.
• Support manufacturing course/certification in the applicable LMS System.
• Support on-the-job training plan to assure personnel compliance.
• Works with document changes in the applicable system (ex. change of manufacturing / quality document changes in Agile)