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.

📌 Quality Engineer III (Ciudad Apodaca)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Ciudad Apodaca