Job DescriptionEnsure that manufacturing processes comply with quality standards performing follow-ups and monitoring the Notifications generated, process validations and defect trends, in accordance with international industry practices and regulations (ISO 13485, 21 CFR820); to meet the objectives of the quality department, providing support in corrective and preventive actions (CAPAS) and implementing actions that generate defect reduction.
Roles & Responsibilities: Use Personal Protective Equipment.
Participates in the emergency brigades and Health and Safety commission, when required.
Use devices, accessories, tools and equipment according to the process; verifying that they are in good conditions of use and reporting those that are in poor condition for repair.
Communicates unsafe acts or conditions to their superiors.
Participates in the Health and Safety courses established by the Company.
Maintains order and cleanliness in the workstation (5's) under your responsability.
Prepares trend reports of PL's (Process Log) and Quality Notifications (VR's, NCR's, EE's) performing analysis of major offenders.
Follow up on Quality Notifications (VR's, NCR's, EE's) open for Mexicali and Corporate locations that affect assigned products (PDIA, History Check and Root Cause Analysis)
Participates in the development of lines, process and / or products validations documenting their results in SAP or Agile systems.
Conducts improvement projects for defect reduction.
Performs mentoring activities for new quality engineers.
Completes the assigned trainings in ISU (Intuitive Surgical University) curriculum
Prepares performance self-assessment for the MERIT process.
Comply with the Organization's Policies, Regulations and Code of Conduct.
Provides feedback clarifying quality controversies to Production Supervisors or FQI Technicians according to regulatory standards.
Participates in Customer Complaint investigations.
Reviews and approves validation protocols performed by Manufacturing Engineering documenting their results in SAP or Agile systems.
Performs formal escalation process (Escalation Decision Form) or report nonconforming product, when required.
Follows up on quality problems of recurring raw material.
Participates in the activities of preparation of Audits and its development.
Drives our Culture Strategy by fostering our mission, founding principles, individual and leadership expectations.
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