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 (Monterrey)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Monterrey