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.

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📌 Senior Quality Engineer (Ejido de la Finca)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Ejido de la Finca