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Manager, Compliance Quality Systems

https://www.baxter.com/ Logo

Baxter

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Ubicación:
Costa Rica , Cartago

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Tipo de contrato:
No proporcionado

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Salario:

No proporcionado
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Descripción del trabajo:

Aquí es donde usted marca la diferencia en la seguridad de nuestros pacientes. Como miembro del equipo de Calidad de Baxter, desempeñará un papel esencial en nuestra misión de salvar y sostener vidas. La calidad es importante durante todo el ciclo de vida del producto y trabaja en colaboración con todas las áreas de la organización. Debido a que Calidad afecta todo lo que hace Baxter, un rol en Calidad brinda muchas oportunidades de crecimiento, aprendizaje y una carrera exitosa que tiene un impacto diario en la vida de las personas. You as Manager, Compliance Quality Systems, will be responsible for the quality assurance function at the plant level, ensuring regulatory compliance, adaptability of manufacturing processes, and operational quality. The mission of the position is to guarantee product quality and customer happiness. This is achieved by implementing management systems, controlling risks, improving continuously, and encouraging employee growth. All actions align with the business’s strategic objectives. Supervises the work of the engineers and technical personnel in charge, with the aim of guaranteeing compliance with the established specifications and ensuring the development and performance of the related quality systems.

Responsabilidades:

  • Quality System Management: Ensure the establishment, maintenance and improvement of a quality system that meets regulatory, normative and corporate requirements
  • Approve local specifications and procedures as a Quality Representative
  • Act as the Quality function’s liaison during internal and external audits and interactions with regulatory bodies
  • Risk Management and Compliance: Implement strategies to identify, assess, and mitigate quality risks in processes, equipment and materials
  • To control the accurate administration of the material and human resources required for compliance with processes
  • Technical and Business Leadership: Provide authority support to both on-site and off-site customers to ensure compliance with plant goals and company standards
  • Promote improvement, simplification, innovation and consistency to regulatory standards projects
  • Represent the Director of Quality in their absence and in strategic committees
  • People Management and Talent Development: Build and complete development and training plans for the members of the department passionate about Quality
  • Ensure the continuous training and development of the teams responsible for Quality Engineering
  • Promotes a culture of quality, safety and continuous improvement at all levels of the organization

Requisitos:

  • Academic background: Quality, Industrial, Chemical, Biomedical or related Engineering
  • 10+ years in Quality roles, with at least 5 in leadership positions
  • Validated experience in quality management systems in the medical, biotechnology or pharmaceutical industry
  • In-depth knowledge of international laws and standards (ISO 13485, FDA, GMP, MDSAP, among others)
  • Technical skills: Process engineering, validations and quality controls
  • Risk analysis and problem-solving tools (FMEA, Six Sigma, CAPA)
  • Audit and regulatory compliance management
  • Proficiency in oral and written English
  • Leadership proficiencies: Inspiring and focused leadership
  • Effective communication and collaborator management
  • Ability to develop high-performing teams
Lo que ofrecemos:
  • Apoyo a las padres
  • Educación continua/ Desarrollo profesional
  • Salud de los empleados y Beneficios de bienestar
  • Tiempo libre pagado
  • 2 días al año para ser voluntario

Información adicional:

Oferta publicada:
26 de enero de 2026

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