Quality Project Engineer Assurance of Supply

hace 4 días

Iztapalapa, México BD A tiempo completo

**Job Description Summary**: ¿Quieres pertenecer a una empresa líder global en tecnología médica que actúa para impulsar el mundo de la salud? Sea parte de algo grandioso

BD es una de las compañías de tecnología médica más grandes del mundo. Tenemos una posición única en el mercado con soluciones para mejorar el manejo de la enfermedad y el manejo de la atención, apoyando a clientes, profesionales de la salud y pacientes en la mejora de la práctica clínica. A nível mundial, somos más de 65.000 empleados apasionados por lo que hacemos y estamos comprometidos a impulsar el mundo de la salud con soluciones desde el diagnóstico hasta el tratamiento.

Pharmaceutical Systems (PS)

Con innovadoras jeringas prellenables, sistemas de auto inyección, sistemas de seguridad y tecnologías de agujas, el equipo de Pharmaceutical Systems (PS) ofrece una amplia selección de soluciones diseñadas para proteger, empaquetar y administrar terapias con medicamentos.

Descripción:

- Reporting into the Design Assurance organization, the WW Quality Engineer is a team member representing WW Quality on sustaining engineering projects.
- He/she plans and delivers Quality Engineering activities to secure milestone/commitment achievement. He/she sets priorities for self and contribute to team planning.
- He/she is responsible for combining design control expertise, problem-solving approaches and analytical skills to support product maintenance using quality engineering skills including but not limited to risk management, process validation and control strategies.
- In addition, this position plays an active role in the processes to ensure products meet customer/patient needs and quality standards consistently with both corporate and unit policies, while meeting all design control and other regulatory applicable requirements.

Lo que requieres:

- Typically requires an Engineer/ master’s degree in Quality management or Science with a minimum of 2 years’ relevant experience like high volume and regulated industrial environment
- Healthcare/Pharmaceutical/ Biologics/Medical Devices experience is a plus )
- Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
- Knowledge of design control principles.
- Good understanding of statistical methods for Quality Assurance +
- Experience in Quality System, Validation.
- Knowledge and experience in manufacturing
- Excellent problem solving and analytical skills
- Ability to handle multiple product & process design related projects, from product inception through product launch and maintenance in an unsupervised environment.
- Good written and oral communication skills including in English language
- Promotes work in multidisciplinary teams.
- Rigor and good organization.

To support Nouvel Projects

**Primary Work Location**: MEX Cuautitlan Izcalli

**Additional Locations**:
**Work Shift**:

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