Quality Assurance Engineer

Bayer AG; Tlaxcala de Xicohténcatl; Presencial; MXN 360.000 - 480.000; Jornada completa

Descripción de la vacante

Bayer AG is seeking a Quality Assurance Engineer in Tlaxcala, Mexico, to act as Qualified Person (QP) and ensure GMP-compliant batch releases for medicinal products. The role involves reviewing processes, maintaining ISO certifications, and driving continuous improvement across QA activities.

Responsibilities include process inspections, deviation analysis, CAPA implementation, and collaboration with regulatory partners to uphold quality and compliance across operations.

Formación

• Bachelor's degree in engineering or similar field.
• At least 3 years of QA/QC or related experience.
• Strong leadership and communication abilities.
• Knowledge of quality control regulations and standards.
• Proficiency with quality control tools and software.

Responsabilidades

• Perform inspections and review process documents to ensure compliance with quality standards and regulatory requirements.
• Monitor production processes, identify deviations, and generate KPI reports.
• Maintain ISO 9001, ISO 14001, and ISO 45001 certifications through audits and improvements.
• Support Integrated Management System focusing on quality and regulatory alignment.
• Investigate customer complaints, determine root causes, and implement CAPA plans.
• Support system implementations and continuous improvement initiatives.

Conocimientos

Leadership

Communication skills

Quality control

Results oriented

Educación

Bachelor's degree in engineering

Herramientas

SAP

Descripción del empleo

Quality Assurance Engineer

Fecha: 1 sept 2026

Quality Assurance Engineer

Serves as the Qualified Person (QP) as required by governing regulations, ensuring the quality and legitimacy of medicinal products. Responsible for maintaining all necessary processes and procedures for QP certification, overseeing batch release, and ensuring compliance with GMP and regulatory requirements for products manufactured in the country. The QP certifies that each production batch meets the required quality standards and documents this certification appropriately.

Job Description

• Perform inspections and process documents on products, intermediates, and raw materials to ensure compliance with specified quality standards and regulatory requirements.


• Monitor and analyze production and processes to identify deviations, trends, defects, and improvement opportunities; generate reports and track KPI performance.


• Maintain and uphold ISO 9001 certification, and support ISO 14001, and ISO 45001 certificationsthrough systematic audits, documentation, and continuous improvement initiatives.


• Maintain and support theIntegrated Management System focused on the quality pillar improving operational controls, and quality assurance protocols aligned with internal regulations and legal requirements.


• Investigate customer complaints, identify root causes, and develop, implement, and monitor corrective action plans (CAPA).


• Support Product Supply System (PSS) implementation and continuous improvement initiatives usingLeantools to drive process efficiency, safety, and cost optimization.


• Lead quality training programs for all employees, building a consistent quality culture across the organization, including specialized training for QHSE team members.


• Support technology development and transfer projects in collaboration with business and production functions.

Reporting & Key Relationships

• Internal:Regional and local Partners, Quality Regional & Global Partners, Regional and Global Regulatory Partners.


• External:Government Departments, Laboratory Service Providers, Tollers, Auditors.

Required Qualifications

• Bachelor's degree in engineering (Biochemical, Chemical, Industrial, Process & Design, or similar).


• Minimum3 yearsof experience in quality control, quality assurance, or related areas.


• Demonstrated leadership with effective facilitation and communication skills.


• Broad understanding of legal requirements and quality control regulations, standards, and methodologies.


• Proficiency in quality control tools and software.


• Strong results orientation with effective prioritization skills.

Technical & Systems Knowledge

• ISO 9001, 14001 and 45001.


• Integrated Management System (SIG)


• SAP


• Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP)