Quality Systems Specialist
Aviso de fuente externaen Outset Medical, Inc.
Support and improve the Quality Management System at Outset Medical, Inc., including audits, document control, training, and CAPA activities.
Salario
No especificado
Ubicación
Tijuana, México
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Quality Systems Specialist
Tijuana, México
Descripción del empleo
About the role
Outset Medical, Inc. is seeking a Quality Systems Specialist to support, maintain, and continuously improve the Quality Management System (QMS). The role supports document control, training, change control, nonconformance, and CAPA activities, with an emphasis on ISO-13485 and FDA 21 CFR 820.
Responsibilities
- Support monitoring and continuous improvement of Quality Management System processes.
- Collaborate with Engineering, Manufacturing, and Quality teams to develop and sustain quality processes.
- Support preparation and execution of internal and external audits.
- Monitor and trend Quality Management System nonconformances and quality data for escalations.
- Drive training activities and tracking to support compliance with applicable regulations and key performance indicators.
- Assist with generating, analyzing, and presenting quality metrics.
- Support the Corrective and Preventive Action (CAPA) program, including coaching CAPA owners and driving comprehensive, audit-ready investigations and effectiveness checks.
- Support document control, including review, approval, and change management within the electronic QMS.
- Track and assess new or revised external standards and regulatory requirements to help maintain 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.
Requirements
- 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.
Datos clave
- Requires a bachelor’s degree in engineering, medical, science, or equivalent experience.
- Requires a minimum of 3 years of experience supporting quality systems within a regulated environment.
- The role supports the Quality Management System, including audits, document control, training, and CAPA activities.
Preguntas frecuentes
What does the Quality Systems Specialist do?
The specialist supports, maintains, and continuously improves the Quality Management System. The role includes document control, training, change control, nonconformance, and CAPA activities.
What qualifications are required?
A bachelor’s degree in engineering, medical, science, or equivalent experience is required. The listing also requires a minimum of 3 years of experience supporting quality systems within a regulated environment.
What standards does the role emphasize?
The role ensures compliance with applicable global regulations and standards, with a specific emphasis on ISO-13485 and FDA 21 CFR 820.