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 skills
MXOPS
Tipo de puesto: Jornada completa
Sueldo: $100.00 - $200.00 al mes
Beneficios:
- Seguro de gastos médicos mayores
- Seguro dental
Lugar de trabajo: Empleo presencial

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