Quality Engineer II - Validation & GMP Compliance

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. 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.