Quality Systems Validation Engineer I

Fresenius Medical Care; Reynosa; Presencial; MXN 300,000 - 400,000; Jornada completa

Descripción de la vacante

A leading medical device company is seeking a Quality Systems Engineer I to support the development and improvement of quality processes. Candidates should have a Bachelor's degree, bilingual skills in English and Spanish, and knowledge of FDA regulations and process validation. This full-time role requires strong problem-solving skills and the ability to work with minimal supervision, with opportunities for career growth in a dynamic environment.

Formación

• 0 - 2 years of experience in Quality Engineering or process validation required.
• Knowledge of FDA regulatory requirements and statistical problem-solving.
• Good organizational skills and ability to work with little supervision.

Responsabilidades

• Participates in developing and improving the facility's Quality Plan.
• Performs plant investigations into product complaints.
• Analyzes processes and quality data to identify causes of failures.

Conocimientos

Bilingual (English / Spanish)

Knowledge of process validation (IQ OQ PQ)

Analytical instrumentation

Statistical process control

Microsoft Office

Technical writing

Educación

Bachelor's Degree in Engineering, Science, Chemistry, or Biology

Herramientas

Minitab

Python

FDA Regulations knowledge

Descripción del empleo

A leading medical device company is seeking a Quality Systems Engineer I to support the development and improvement of quality processes. Candidates should have a Bachelor's degree, bilingual skills in English and Spanish, and knowledge of FDA regulations and process validation. This full-time role requires strong problem-solving skills and the ability to work with minimal supervision, with opportunities for career growth in a dynamic environment.