Senior Quality Assurance Engineer — Medical Devices & Compliance

BEPC Inc. - Business Excellence Professional Consulting; Guadalupe; Presencial; MXN 400.000 - 700.000; Jornada completa

Descripción de la vacante

BEPC Inc. – Business Excellence Professional Consulting seeks a Senior Quality Assurance Engineer in Mexico to drive compliance and continuous improvement in a regulated manufacturing setting.

You will lead CAPA management, audits, change control, and risk analysis, applying Lean Six Sigma, DOE, and TMV to prevent defects and improve product quality. You will collaborate with Production, Engineering, and other plant functions to ensure the integrity of design, materials, and processes as changes

Formación

• Bachelor’s degree or higher in Industrial, Biomedical, Mechanical, Chemical, Electrical, or Mechatronics Engineering or related field.
• 3+ years of experience establishing, controlling, and improving Quality Systems.
• Knowledge of statistical methods and familiarity with Lean Six Sigma or continuous improvement.
• Experience in Medical Device or Pharmaceutical manufacturing preferred.
• ISO 13485, ISO 9001, or ISO 17025 certification preferred.
• Experience in problem solving, investigations, test analysis, and disposition of nonconforming products.
• Knowledge of Change Control systems and risk analysis.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Teams).
• Strong leadership and communication skills with a data-driven, collaborative mindset.

Responsabilidades

• Ensure compliance with quality standards.
• Establish and maintain quality systems.
• Prevent product and process defects.
• Lead quality audits.
• Manage CAPAs.
• Support process and product validation activities.
• Lead improvements using Six Sigma, DOE, TMV, and IQ/OQ/PQ.
• Interact with customers on complaint investigations and analysis.
• Coordinate with cross-functional teams.

Conocimientos

Lean Six Sigma

Statistical methods

Problem solving

Leadership

Communication

Data-driven

Teamwork

MS Office

Educación

Bachelor’s degree in Industrial, Biomedical, Mechanical, Chemical, Electrical, or Mechatronics Engineering

Herramientas

Microsoft Office

Descripción del empleo

BEPC Inc. – Business Excellence Professional Consulting seeks a Senior Quality Assurance Engineer in Mexico to drive compliance and continuous improvement in a regulated manufacturing setting.

You will lead CAPA management, audits, change control, and risk analysis, applying Lean Six Sigma, DOE, and TMV to prevent defects and improve product quality. You will collaborate with Production, Engineering, and other plant functions to ensure the integrity of design, materials, and processes as changes