Quality Systems Specialist

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

The Quality Systems Specialist is responsible for supporting, maintaining, and continuously improving the Quality Management System (QMS).

This role supports quality system processes including document control, training, change control nonconformance, and CAPA activities. The specialist monitors quality metrics, assists with audits, and ensures compliance with applicable global regulations and standards with a specific emphasis on ISO-13485 and FDA 21 CFR 820.

Essential Job Functions and Responsibilities

• 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 all applicable regulations and key performance indicators.
• Assist with generation, analysis, and presentation of quality metrics.
• Support the Corrective and Preventive Action (CAPA) program, including coaching CAPA owners, drive comprehensive and audit-ready investigations and effectiveness checks.
• Support document control activities, including review, approval, and change management within the electronic QMS.
• Track and assess new or revised external standards and regulatory requirements ensuring that involved processes are maintained for continued compliance.
• Ensure adherence to company procedures and applicable regulatory and quality standards.
• Maintain effective working relationships with internal and external stakeholders.
• Support additional quality system activities as assigned.

Required Qualifications

• Bachelor’s degree in engineering, medical, science, or equivalent experience. Previous experience in the role can be considered.
• Minimum of 3 years of experience supporting quality systems within a regulated environment.
• Experience in the medical device field is required; preferably experience with disposable and capital equipment medical devices.
• Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.
• Fluent in English (written and verbal).

Desired Qualifications

• Strong interpersonal skills and ability to work cross-functionally.
• Ability to work effectively in a fast-paced and dynamic environment.
• Self-motivated with strong organizational skills.
• Strong written and verbal communication skills.
• Lead Auditor Certification preferred.
• Certification or training in Lean Six Sigma is a plus.