Senior Quality Assurance Engineer

hace 18 horas


Mexicali, Baja California, México Buscojobs México A tiempo completo

About the Role:

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Buscojobs México. As a key member of our quality department, you will be responsible for ensuring that our manufacturing processes comply with quality standards.

Key Responsibilities:

  • Perform follow-ups and monitoring of Notifications generated, process validations, and defect trends in accordance with international industry practices and regulations (ISO 13485, 21 CFR820).
  • Meet the objectives of the quality department by providing support in corrective and preventive actions (CAPAS) and implementing actions that generate defect reduction.
  • Prepare 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 assigned products (PDIA, History Check, and Root Cause Analysis).
  • Participate in the development of lines, process, and/or product validations documenting their results in SAP or Agile systems.
  • Conduct improvement projects for defect reduction.
  • Perform mentoring activities for new quality engineers.
  • Comply with the Organization's Policies, Regulations, and Code of Conduct.
  • Provide feedback clarifying quality controversies to Production Supervisors or FQI Technicians according to regulatory standards.
  • Participate in Customer Complaint investigations.
  • Review and approve validation protocols performed by Manufacturing Engineering documenting their results in SAP or Agile systems.

Requirements:

  • Bachelor's Degree in any engineering field.
  • English language skills: Advanced 80%.
  • Job or area experience: Quality Engineer or Manufacturing Engineer with 5 years of experience.
  • Knowledge/skills: Lean Manufacturing, Knowledge in ISO-13485, 21CFR820, Troubleshooting techniques (CAPA System, 5 why's, Fish Diagrams, 8 D's), or similar Six Sigma and statistical tools (MSA-Measurement System Analysis, DOE-Design Of Experiments, Process Capability, SPC-Statistical Process Control, PFMEA-Process Failure Mode and Effect Analysis).


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