Global Sterility & Microbiology Lead (Medical Devices)

Ambu A/S; Ciudad Juárez; Presencial; MXN 1,281,000 - 1,740,000; Jornada completa

Descripción de la vacante

A leading medical devices company is seeking a Sterility Assurance & Microbiology Lead to manage microbiology and sterilization activities at their manufacturing facility in Ciudad Juárez, Mexico. The ideal candidate will have a Bachelor's degree, over 5 years of Quality experience, and knowledge in cGMP and ISO standards. This role will involve conducting sterility assessments, bioburden testing, and ensuring compliance with health standards. The company offers a dynamic work environment focusing on safety and quality.

Formación

• 5+ years of experience working in Quality.
• Experience in the medical device industry.
• Experience working in manufacturing is preferred.
• Able to read, write, and understand English.

Responsabilidades

• Contribute to technical feasibility analysis for sterility assurance.
• Design and perform Sterility Assurance Assessments.
• Conduct bioburden testing and analyze results.
• Prepare materials for cleanroom monitoring.

Conocimientos

Technical feasibility analysis

Microbiology inputs

Analytical process tools

Good Documentation Practices (GDP)

Knowledge of cGMP and ISO standards

Educación

Bachelor's degree in a related field

Descripción del empleo

A leading medical devices company is seeking a Sterility Assurance & Microbiology Lead to manage microbiology and sterilization activities at their manufacturing facility in Ciudad Juárez, Mexico. The ideal candidate will have a Bachelor's degree, over 5 years of Quality experience, and knowledge in cGMP and ISO standards. This role will involve conducting sterility assessments, bioburden testing, and ensuring compliance with health standards. The company offers a dynamic work environment focusing on safety and quality.