Quality & Validation Engineer

Mexicali, Baja California
Industria: Dispositivos Médicos

About the role

We are looking for a Quality & Validation Engineer to lead process validations across the site, ensuring compliance with company, customer, and regulatory requirements (ISO 13485 / 21 CFR).

Key Responsibilities
- Develop and execute validation plans for new and existing processes
- Collaborate with cross-functional teams (Quality, Manufacturing, NPI, Supply Chain)
- Perform data analysis and statistical validation (Minitab preferred)
- Participate in FMEA and risk management activities
- Create and maintain validation documentation and reports
- Drive continuous improvement initiatives
- Support supplier validation requirements
- Coach engineering teams on validation best practices





Requirements:
- Bachelor’s degree in Engineering or related field
- 5-7+ years of experience in Quality / Manufacturing
- Experience in ISO 13485 and/or 21 CFR environments
- Experience in Medical Device industry (preferred)
- Lean Six Sigma Green Belt (Black Belt is a plus)
- Advanced English

Pregunta(s) de postulación:
- ¿Cuál es tu expectativa salarial diaria antes de impuestos?
- ¿Tienes experiência con la ISO 13485?

Escolaridad:
- Licenciatura terminada (Deseable)

Idioma:
- Inglés Avanzado (Obligatorio)

Lugar de trabajo: Empleo presencial

📌 Quality and Validation Engineer (Mexicali)
🏢 PRODENSA SERVICIOS DE CONSULTORIA - principal
📍 Mexicali