QMS Specialist: ISO/FDA Compliance & CAPA Lead

Outset Medical, Inc.; Tijuana; Presencial; MXN 420.000 - 540.000; Jornada completa

Descripción de la vacante

Outset Medical, Inc. is seeking a Quality Systems Specialist to support and enhance the Quality Management System (QMS) globally, with emphasis on ISO-13485 and FDA 21 CFR 820 compliance. This role collaborates with Engineering, Manufacturing, and Quality teams to drive CAPA, training, and metrics.

The ideal candidate has a Bachelor’s degree in a relevant field, 3+ years in regulated quality systems, and fluency in English. Medical device experience is preferred.

Formación

• Bachelor’s degree in engineering, medical, science, or equivalent experience.
• Minimum of 3 years of experience supporting quality systems within a regulated environment.
• Experience in the medical device field is required; preferably disposable and capital equipment.
• Fluent in English (written and verbal).

Responsabilidades

• Support monitoring and continuous improvement of Quality Management System processes.
• Collaborate with Engineering, Manufacturing, and Quality teams on the development and sustaining of quality processes.
• Support internal and external audit preparation and execution activities.
• Monitor and trend Quality Management System nonconformances and quality data for escalations.
• Drive training activities and tracking to ensure compliance with regulations and KPIs.
• Assist with generation, analysis, and presentation of quality metrics.
• Support the CAPA program, including coaching CAPA owners and investigations.
• Support document control activities, including review, approval, and change management within the QMS.
• Track and assess new or revised external standards and regulatory requirements for continued compliance.
• Ensure adherence to company procedures and regulatory standards.
• Maintain relationships with internal and external stakeholders.
• Support additional quality system activities as assigned.

Conocimientos

Quality systems

Document control

CAPA

Audit support

Training management

Quality metrics

Regulatory compliance

Cross-functional

Educación

Bachelor's degree

Descripción del empleo

Outset Medical, Inc. is seeking a Quality Systems Specialist to support and enhance the Quality Management System (QMS) globally, with emphasis on ISO-13485 and FDA 21 CFR 820 compliance. This role collaborates with Engineering, Manufacturing, and Quality teams to drive CAPA, training, and metrics.

The ideal candidate has a Bachelor’s degree in a relevant field, 3+ years in regulated quality systems, and fluency in English. Medical device experience is preferred.