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.

The Senior Quality Assurance Engineer will be responsible for ensuring compliance with and continuous improvement of quality systems and standards, ensuring product and process conformity within a regulated manufacturing environment. This position will play a key role in CAPA management, audits, change control, risk analysis, quality investigations, and process and product validation activities (IQ/OQ/PQ, PPQ, and TMV). The role will also collaborate cross-functionally with Production, Engineering, and other plant functions, applying statistical tools and methodologies such as Lean Six Sigma and DOE to prevent defects, solve quality issues, and drive improvements in product quality and performance.

KEY RESPONSIBILITIES:




- Ensure compliance with quality standards.
- Establish and maintain quality systems.
- Prevent product and process defects.
- Lead quality audits.
- Manage Corrective and Preventive Actions (CAPAs).
- Support process and product validation activities.
- Drive quality improvements for existing products through the use of continuous improvement methods and tools, including Six Sigma, Product and Process Understanding (PPU), Design of Experiments (DOE), Customer Quality Index (CQI), Test Method Validation (TMV), and manufacturing line validation (IQ, OQ, PQ, and PPQ).
- Support and interact with customers through complaint investigations, problem-solving and trend analysis, test investigation and analysis, and disposition of nonconforming products.
- Lead and/or support internal and external audits.
- Ensure that the design intent and integrity of marketed products are maintained as materials, processes, methods, and specific

📌 Sr. Quality Assurance Engineer (Isla Guadalupe)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Isla Guadalupe