Ingeniero de Calidad & Validaciones

BEPC Inc. - Business Excellence Professional Consulting; Apodaca; On-site; MXN 360,000 - 540,000; Full time

Job summary

BEPC Inc. is seeking a Quality and Validation Engineer to support QA and validation activities within medical device manufacturing.

This role will develop and execute validation protocols, investigate quality issues, and support continuous improvement while ensuring compliance with GMP, GDP, and documentation requirements. The ideal candidate holds a Bachelor's degree in Engineering, has hands-on experience with IQ, OQ, PQ, and is proficient in statistical tools (e.g., Minitab).

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Previous experience in medical device manufacturing is required.
• Experience in quality engineering and equipment or process validation.
• Hands-on experience developing and executing IQ, OQ, and PQ protocols.
• Working knowledge of GMP, GDP, root cause analysis, CAPA, and nonconformance management.
• Ability to interpret technical requirements and prepare clear validation and quality reports.
• Ability to understand and speak English, participate in meetings, and communicate technical information.
• Strong analytical, organizational, and problem-solving skills.
• Availability to work on-site in Apodaca, Nuevo León.

Responsibilities

• Develop, execute, and document IQ, OQ, PQ protocols for manufacturing equipment and processes.
• Prepare validation plans, analyze results, document deviations, and generate validation completion reports.
• Support pre-validation studies and establish acceptance criteria with cross-functional teams.
• Investigate nonconformances, perform root cause analysis, and support CAPA.
• Review manufacturing and quality documentation for accuracy, completeness, and compliance with GMP and GDP.
• Support risk assessments, change control, and evaluation of changes affecting validated equipment and processes.
• Apply statistical tools to evaluate process performance and support validation conclusions.
• Collaborate with Manufacturing, Engineering, Quality, and Maintenance to resolve issues and improve process reliability.
• Support internal and external audits by providing validation records and quality documentation.

Skills

Analytical skills

Organizational skills

Problem solving

English communication

Education

Bachelor's degree in Engineering or related field

Tools

Minitab

Job description

BEPC Inc. is seeking a Quality and Validation Engineer to support quality assurance and validation activities within medical device manufacturing. This role will develop and execute validation protocols, investigate quality issues, and support continuous improvement while ensuring compliance with established quality procedures and documentation requirements.

Key Responsibilities

• Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing equipment and processes.
• Prepare validation plans, analyze results, document deviations, and generate validation completion reports.
• Support pre-validation studies and establish acceptance criteria with cross-functional teams.
• Investigate nonconformances, perform root cause analysis, and support corrective and preventive actions (CAPA).
• Review manufacturing and quality documentation for accuracy, completeness, and compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Support risk assessments, change control, and evaluation of changes affecting validated equipment and processes.
• Apply statistical tools to evaluate process performance and support validation conclusions.
• Collaborate with Manufacturing, Engineering, Quality, and Maintenance to resolve issues and improve process reliability.
• Support internal and external audits by providing validation records and quality documentation.

Basic Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Previous experience in medical device manufacturing is required.
• Experience in quality engineering and equipment or process validation.
• Hands-on experience developing and executing IQ, OQ, and PQ protocols.
• Working knowledge of GMP, GDP, root cause analysis, CAPA, and nonconformance management.
• Ability to interpret technical requirements and prepare clear validation and quality reports.
• Ability to understand and speak English, participate in meetings, and communicate technical information.
• Strong analytical, organizational, and problem-solving skills.
• Availability to work on-site in Apodaca, Nuevo León.

Preferred Qualifications

• Experience with Test Method Validation (TMV) and measurement system analysis.
• Proficiency in Minitab or similar statistical software.
• Familiarity with medical device quality management systems, including ISO 13485.
• Experience supporting equipment transfers, new product introductions, or manufacturing process improvements.Knowledge of Lean Six Sigma and Design of Experiments (DOE).