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.**Validation / NPI Engineer** to support medical device manufacturing operations in a regulated environment.This role will focus on **process validation, new product introductions, and quality assurance support**, ensuring compliance with internal procedures and regulatory requirements.**KEY RESPONSABILITIES**:- Develop, execute, and document **EIQ, IQ, OQ, PQ, and CSV** validation activities.- Support validation of new equipment, machines, and production lines.- Participate in **New Product Introduction (NPI)** projects from development through production release.- Prepare, review, and approve validation protocols, reports, and technical documentation.- Support **QA activities**, including nonconformance management, defect classification, and rework approvals.- Generate and manage **Nonconformance Records (NCRs)** using **EtQ Reliance**.- Develop and update **test methods and sampling plans**.- Perform **capacity studies, data analysis, and process optimization**.- Maintain and update manufacturing documentation (BOMs, PFMEAs, specifications,



drawings).- Support preventive maintenance and equipment qualification activities.- Collaborate with cross-functional teams (Manufacturing, QA, R&D;, Supply Chain)**QUALIFICATIONS**:- Bachelor's degree in Engineering (Industrial, Systems, Computer, or related fields).- 2 to 3 years of experience working with MES systems.- Strong understanding of programming logic.- Proficiency in SQL configuration language.- Experience in data analysis and interpretation.- Excellent problem-solving skills and attention to detail.- Ability to work in a regulated environment with a focus on quality and compliance.- Upper-intermediate level of English (reading and writing) and intermediate English conversation skills.**Required Qualifications**- Bachelor's degree in **Biomedical Engineering** or related engineering field.- Experience in **medical device manufacturing** or other regulated industries.- Solid knowledge of **process validation and quality systems**.- Experience working with manufacturing and quality documentation.- **Advanced English level** (written and verbal).**Preferred Skills & Tools**- Validation protocols**:EIQ, IQ, OQ, PQ, CSV**:- Quality systems**:EtQ Reliance**:- ERP systems**:Oracle, SAP**:- Statistical tools**:Minitab, Matlab, Python**:- CAD tools**:DraftSight**:- Strong analytical, problem-solving, and teamwork skillsMXOPSTipo de puesto: Tiempo completoSueldo: $****** - $****** al mesBeneficios:- Confiable de gastos médicos mayores- Seguro dentalLugar de trabajo: Empleo presencial

📌 Qa Engineer (Medical Industry) (Ciudad Juárez)
🏢 Bepc
📍 Ciudad Juárez