Quality Engineer III

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

BEPC Inc. in Mexico seeks a Validation Engineer III – Quality to execute and support validation activities in regulated medical device manufacturing environments. You will work with Engineering, Manufacturing, Quality, R&D, and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, GDP, and QMS requirements.

The role covers IQ/OQ/PQ, CSV, TMV, MVP/MVI/SVMP documentation, risk assessments, DOE, and data analysis to improve process robustness and facilitate inspections and audits.

Formación

• Bachelor's Degree in Engineering or a related field.
• 3–5 years of experience in validation, quality or manufacturing engineering in a regulated environment.
• Experience with IQ/OQ/PQ execution and documentation (FDA 21 CFR Part 820, ISO 13485, GMP, GDP, QMS).
• Experience or working knowledge of CSV and TMV validations.
• Familiarity with MVP, MVI, SVMP documentation and validation lifecycle management.
• Knowledge of risk-based validation methodologies.
• Working knowledge of DOE and statistical analysis.
• Experience supporting CAPA, deviations, non-conformances, and change control.
• Familiarity with calibration and preventive maintenance documentation.
• Knowledge of Lean Manufacturing, Six Sigma, DMAIC, and continuous improvement.

Responsabilidades

• Execute and support validation activities for manufacturing processes, equipment, test methods, and computerized systems.
• Write, review, and execute OQ, PQ, CSV, TMV, FAT, SAT.
• Support MVP, MVI, SVMP documentation and validation lifecycle.
• Develop validation protocols, reports, and other technical documents per FDA/ISO/QMS requirements.
• Support DOE and statistical analyses for validation.
• Participate in risk assessments, feasibility studies, and experimental runs.
• Coordinate validation deliverables to meet timelines and regulatory requirements.
• Provide support during audits and regulatory inspections.
• Support deviation investigations, CAPAs, non-conformances, and change control.
• Apply Lean/Six Sigma methods to improve validation efficiency.

Conocimientos

Advanced English proficiency

Strong communication

Strong written documentation

Collaboration and teamwork

Project management basics

Lean Manufacturing

Six Sigma

DOE and statistical analysis

Educación

Bachelor's Degree in Engineering

Descripción del empleo

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 Validation Engineer III – Quality to execute and support validation activities within regulated medical device manufacturing environments. This role will support process, equipment, test method, and computerized system validations, including the development and execution of IQ/OQ/PQ protocols, Computer Systems Validation (CSV), and Test Method Validation (TMV) activities. The Validation Engineer III will work cross-functionally with Engineering, Manufacturing, Quality, R&D, and Regulatory teams to ensure validation activities comply with FDA regulations, ISO 13485, GMP, GDP, and internal Quality Management System (QMS) requirements.

KEY RESPONSIBILITIES:

• Execute and support validation activities for manufacturing processes, equipment, test methods, and computerized systems.
• Write, review, and execute:
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Computer Systems Validation (CSV)
  • Test Method Validation (TMV)
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
• Support the maintenance and execution of validation activities associated with the Master Validation Plan (MVP), Master Validation Index (MVI), and Site Validation Master Plan (SVMP).
• Develop validation protocols, reports, forms, and supporting technical documentation in accordance with FDA, ISO 13485, GMP, GDP, and QMS requirements.
• Support the design and execution of Design of Experiments (DOE) and statistical analysis for validation activities.
• Participate in pre-validation activities, including risk assessments, feasibility studies, and experimental runs.
• Coordinate validation deliverables to ensure completion according to project timelines and regulatory requirements.
• Provide technical support during internal/external audits and regulatory inspections.
• Support and participate in deviation investigations, CAPAs, non-conformance investigations, and change control activities.
• Apply risk-based validation approaches to determine appropriate validation strategies and testing requirements.
• Support the creation and maintenance of calibration and preventive maintenance records in accordance with QMS requirements.
• Collaborate cross-functionally with Manufacturing, Quality, R&D, Engineering, and Regulatory Affairs.
• Apply Lean Manufacturing, Six Sigma/DMAIC, and continuous improvement methodologies to improve validation efficiency and process robustness.
• Prepare validation data and documentation required for validation closure reports.
• Ensure validation activities and documentation comply with applicable Good Documentation Practices (GDP).

MAIN QUALIFICATIONS:

• Bachelor's Degree in Engineering or a related technical field.
• Approximately 3–5 years of experience in validation, quality engineering, manufacturing engineering, or related activities, preferably within the medical device industry or another regulated manufacturing environment.
• Practical experience with IQ/OQ/PQ execution and documentation.
  • FDA regulations / 21 CFR Part 820
  • ISO 13485
  • GMP
  • GDP
  • Quality Management Systems (QMS)
• Experience or working knowledge of CSV and TMV validations.
• Familiarity with MVP, MVI, and SVMP documentation and validation lifecycle management.
• Knowledge of risk-based validation methodologies.
• Working knowledge of DOE and statistical analysis.
• Experience supporting CAPA, deviations, non-conformances, and change control.
• Familiarity with calibration and preventive maintenance documentation.
• Knowledge of Lean Manufacturing, Six Sigma, DMAIC, and continuous improvement methodologies.
• Working knowledge of project management principles.
• Strong technical writing and documentation skills.
• Advanced English proficiency, written and verbal.
• Strong communication, organization, collaboration, and presentation skills.