Senior Quality Engineer — Medical Devices (ISO 13485)

Insulet; Nuevo León; Presencial; MXN 1,282,000 - 1,649,000; Jornada completa

Descripción de la vacante

A healthcare technology company located in Nuevo León is seeking a Senior Quality Engineer. This role involves ensuring products meet quality standards in compliance with FDA regulations. Candidates should possess a BS in engineering, 5-7 years of experience in regulated environments, and strong communication skills. This position offers the opportunity to work collaboratively within a dynamic team and significantly impact product quality initiatives.

Formación

• 5-7 years’ experience in an FDA regulated environment.
• Experience with QSR Part 820, ISO 13485, and ISO 14971.
• Experience with methods for design, verification, and validation of medical devices.

Responsabilidades

• Ensure new product introduction quality deliverables are executed.
• Support Risk Management activities from product concept through commercialization.
• Review and approve design control documentation for compliance.

Conocimientos

Effective verbal and written communication skills

Problem solving / root cause analysis skills

Collaboration and communication skills

Ability to organize and judge priorities

Educación

BS degree in engineering or a technical/scientific discipline

Master’s degree preferred

Descripción del empleo

A healthcare technology company located in Nuevo León is seeking a Senior Quality Engineer. This role involves ensuring products meet quality standards in compliance with FDA regulations. Candidates should possess a BS in engineering, 5-7 years of experience in regulated environments, and strong communication skills. This position offers the opportunity to work collaboratively within a dynamic team and significantly impact product quality initiatives.