Senior QA Engineer: Medical Devices & Compliance

BEPC Inc. - Business Excellence Professional Consulting; Apodaca; On-site; MXN 420,000 - 560,000; Full time

Job summary

BEPC Inc. Mexico seeks a Quality Assurance Engineer to establish, maintain, and improve the Quality Management System, ensuring products meet quality requirements, regulations, and customer expectations.

You will lead audits, CAPA, and risk analyses, support TMV and manufacturing validations, and drive Six Sigma and DOE-based continuous improvement while ensuring compliance with ISO 13485 and FDA/ EU MDR requirements.

Qualifications

• Bachelor’s degree or higher in the stated fields.
• At least 3 years in engineering, quality, or similar roles establishing and improving quality systems.
• Practical knowledge of root cause analysis, change control, and risk analysis.
• Statistical knowledge and 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.

Responsibilities

• Maintain and improve the Quality Management System and prevent defects.
• Lead and participate in internal and external audits.
• Manage CAPA, complaint investigations, and trend analysis.
• Perform root cause analysis and support disposition of nonconforming products.
• Support TMV and manufacturing line validation through IQ, OQ, PQ, and PPQ.
• Drive continuous improvement using Six Sigma, statistical tools, and DOE.
• Participate in change control and risk analysis while preserving product integrity.
• 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.
• Supervise quality technicians and inspectors and indirectly supervise other quality engineers.
• Promote a culture of quality, customer service, and safety.

Skills

Six Sigma

DOE

Root cause analysis

Change control

Risk analysis

Statistical tools

Quality metrics

Education

Bachelor's degree or higher in Industrial, Biomedical, Mechanical, Chemical, Electrical, or Mechatronics Engineering, or Microbiology

Tools

Microsoft Office

Job description

BEPC Inc. Mexico seeks a Quality Assurance Engineer to establish, maintain, and improve the Quality Management System, ensuring products meet quality requirements, regulations, and customer expectations.

You will lead audits, CAPA, and risk analyses, support TMV and manufacturing validations, and drive Six Sigma and DOE-based continuous improvement while ensuring compliance with ISO 13485 and FDA/ EU MDR requirements.