Senior Quality Assurance Engineer
hace 18 horas
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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