QA Engineer - Medical Devices (CAPA, Validation, ISO)

BEPC Inc. - Business Excellence Professional Consulting; Apodaca; On-site; MXN 350,000 - 650,000; Full time

Job summary

BEPC Inc. provides specialized engineering solutions and IT project management services, with BEPC Mexico delivering consulting services for automotive and medical device sectors in Mexico and globally.

The Quality Assurance Engineer will ensure compliance with quality standards and drive continuous improvement in a regulated manufacturing environment, collaborating with Production, Engineering, and other functions using Lean Six Sigma and DOE to prevent defects and enhance product quality.

Qualifications

• Bachelor’s degree or higher in an engineering or related scientific field.
• 3+ years of experience establishing, controlling, and improving Quality Systems.
• Knowledge of statistical methods and familiarity with Lean Six Sigma and/or continuous improvement.
• Medical Device or Pharmaceutical manufacturing experience is a must.
• ISO 13485, ISO 9001, and/or ISO 17025 certification is preferred.
• Experience in problem-solving, investigations, test analysis, and disposition of nonconforming products.

Responsibilities

• Ensure compliance with quality standards.
• Establish and maintain quality systems.
• Prevent product and process defects.
• Lead quality audits.
• Manage CAPAs (Corrective and Preventive Actions).
• Support process and product validation activities.
• Drive quality improvements using Six Sigma, DOE, and related methodologies.
• Support customer complaints investigations and trend analysis.
• Lead and/or support internal and external audits.
• Ensure design integrity through changes in materials, processes, methods, and specifications.
• Coordinate with cross-functional teams (Production, Facilities, EHS, etc.).

Skills

Statistical methods

Lean Six Sigma

Problem-solving

Leadership

Data-driven

Education

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

Tools

MS Office

Job description

BEPC Inc. provides specialized engineering solutions and IT project management services, with BEPC Mexico delivering consulting services for automotive and medical device sectors in Mexico and globally.

The Quality Assurance Engineer will ensure compliance with quality standards and drive continuous improvement in a regulated manufacturing environment, collaborating with Production, Engineering, and other functions using Lean Six Sigma and DOE to prevent defects and enhance product quality.