Senior Quality Engineer

Hace 15 horas

monterrey, nuevo león, México BEPC Inc. - Business Excellence Professional Consulting Jornada completa

We are seeking a Quality Assurance Engineer responsible for establishing, maintaining, and improving the Quality Management System to ensure that products and processes meet quality requirements, applicable regulations, and customer expectations.

Responsibilities
  • Maintain and improve the Quality Management System and prevent product and process defects.
  • Lead and participate in internal and external audits.
  • Manage corrective and preventive actions (CAPA), complaint investigations, and trend analysis.
  • Perform root cause analysis and support the disposition of nonconforming products.
  • Support test method validation (TMV) and manufacturing line validation through IQ, OQ, PQ, and PPQ.
  • Drive continuous improvement using Six Sigma, statistical tools, and Design of Experiments (DOE).
  • Participate in change control and risk analysis while preserving product integrity and design requirements.
  • Support changes to materials, processes, methods, specifications, and supply sources.
  • Collect, analyze, and report quality system performance metrics.
  • Collaborate with Production, Facilities, Maintenance, and EHS.
  • Support plant implementation and manufacturing line transfers.
  • Directly supervise quality technicians and inspectors and indirectly supervise other quality engineers.
  • Promote a culture of quality, customer service, and safety.
Requirements
  • A bachelor’s degree or higher in Industrial, Biomedical, Mechanical, Chemical, Electrical, or Mechatronics Engineering, or Microbiology.
  • At least 3 years of experience in engineering, quality, or similar technical roles, including involvement in establishing, controlling, and improving quality systems.
  • Practical knowledge of root cause analysis, change control, and risk analysis.
  • Statistical knowledge and familiarity with Lean Six Sigma or continuous improvement methodologies.
  • Knowledge of ISO 13485, MDSAP, ANVISA, FDA requirements, 21 CFR Part 11, and EU MDR.
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, and Teams.
Preferred Qualifications
  • Experience in medical device or pharmaceutical manufacturing.
  • Certifications in ISO 13485, ISO 9001, or ISO 17025.