Quality Engineer III

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. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

We are seeking a Quality Assurance Engineer II responsible for establishing, maintaining, and improving the Quality Management System to ensure that products and processes meet quality requirements, applicable regulations, and customer expectations.

KEY RESPONSIBILITIES:

• Provide technical engineering support for validation activities in regulated medical device manufacturing environments, including compliance with FDA, ISO 13485, and GMP requirements.
• Write and execute Installation Qualification (IQ) protocols and collect, analyze, and document data to support validation completion reports.
• Write and execute Operational Qualification (OQ) protocols, ensuring validation evidence meets quality and regulatory standards applicable to the medical industry.
• Support the execution of experiments during the pre-validation phase, following risk-based approaches and quality guidelines.
• Ensure assigned validation activities are performed in a timely manner and in accordance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and internal quality procedures.
• Demonstrate working knowledge of validation principles, quality systems, deviation management, and change control within medical manufacturing processes.
• Participate in quality-related activities such as CAPA support, non-conformance investigations, and continuous improvement initiatives.
• Responsible for the execution of validation activities, including the creation and maintenance of calibration and preventive maintenance records in compliance with quality system requirements.

MAIN QUALIFICATIONS:

• 2 – 4 years of experience in medical industry
• Familiarity with Quality Management Systems (QMS) and regulatory standards such as ISO 13485, FDA regulations, and GMP
• Good presentation skills before groups/clients.
• Intermediate knowledge in statistics.
• Basic knowledge of Six Sigma, DMAIC and Kaizen.
• Intermediate English level (reading and writing) with intermediate conversation skills.