Senior QA Engineer - Medical Device Validation & GMP

BEPC Inc. - Business Excellence Professional Consulting; Apodaca; On-site; MXN 360,000 - 600,000; Full time

Job summary

BEPC Inc. Mexico seeks a Quality Assurance Engineer II to establish, maintain, and improve the Quality Management System for medical device products and processes. You will ensure compliance with regulatory requirements and customer expectations across validation activities.

The role involves IQ/OQ validation, CAPA support, and continuous improvement within GMP/GDP frameworks. Strong presentation skills and intermediate English are required.

Qualifications

• 2–4 years of experience in medical industry.
• Familiarity with QMS, ISO 13485, FDA regulations and GMP.
• Good presentation skills before groups/clients.
• Intermediate knowledge in statistics; Six Sigma basics.

Responsibilities

• Provide technical engineering support for validation activities in regulated medical device environments.
• Write and execute IQ protocols and collect data to support validation completion reports.
• Write and execute OQ protocols, ensuring evidence meets quality and regulatory standards.
• Support pre-validation experiments following risk-based quality guidelines.
• Ensure validation activities comply with GMP, GDP, and internal procedures.
• Demonstrate knowledge of validation principles, quality systems, deviation management, and change control.
• Participate in CAPA support, non-conformance investigations, and continuous improvement.
• Execute validation activities and maintain calibration and preventive maintenance records.

Skills

QMS familiarity

Regulatory knowledge

Validation principles

Statistics

Six Sigma basics

English communication

Job description

BEPC Inc. Mexico seeks a Quality Assurance Engineer II to establish, maintain, and improve the Quality Management System for medical device products and processes. You will ensure compliance with regulatory requirements and customer expectations across validation activities.

The role involves IQ/OQ validation, CAPA support, and continuous improvement within GMP/GDP frameworks. Strong presentation skills and intermediate English are required.