Ingeniero de Calidad II

BEPC Inc. - Business Excellence Professional Consulting; Monterrey; On-site; MXN 420,000 - 540,000; Full time

Job summary

BEPC Inc. in the Monterrey area is seeking a Quality Engineer II to join our team focused on validation in regulated medical device environments.

This role supports IQ/OQ activities and ensures compliance with GMP, GDP, and current regulatory requirements, contributing to CAPA and continuous improvement initiatives. The ideal candidate will have 2–4 years in the medical industry with QMS familiarity, knowledge of ISO 13485 and FDA regulations, and intermediate English.

Qualifications

• 2–4 years in medical industry with QMS familiarity.
• Familiar with ISO 13485, FDA regulations, and GMP.
• Good presentation skills before groups/clients.
• Intermediate knowledge of statistics.
• Basic knowledge of Six Sigma, DMAIC and Kaizen.
• Intermediate English reading/writing with conversational ability.

Responsibilities

• Provide technical engineering support for validation activities in regulated medical device environments, including FDA, ISO 13485, and GMP compliance.
• Write and execute IQ protocols and collect data to support validation completion reports.
• Write and execute OQ protocols ensuring validation evidence meets quality and regulatory standards.
• Support pre-validation experiments using risk-based approaches and quality guidelines.
• Ensure validation activities comply with GMP, GDP, and internal quality procedures.
• Demonstrate knowledge of validation principles, quality systems, deviation management, and change control.
• Participate in CAPA support, non-conformance investigations, and continuous improvement initiatives.
• Execute validation activities including creation and maintenance of calibration and preventive maintenance records.

Skills

Quality engineering

Presentation skills

Statistics

English (intermediate)

Six Sigma knowledge

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.

BEPC Inc. is seeking a Quality Engineer II to join our fast-growing team of consultants! in Apodaca, Nuevo Leon area. This position provides technical engineering support for validation activities, ensuring compliance with GMP, GDP, and current regulatory requirements.

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.

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.