Site Head, Quality
hace 3 semanas
Position Overview The Site Head, Quality is a critical member of the senior leadership team at Outset Medical's Tijuana manufacturing site, responsible for overseeing the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO , and other global regulatory standards. This role drives quality excellence in the production of Class II medical devices (hemodialysis systems and consumable cartridges), ensuring patient safety and scalability to meet growing market demand. Key Responsibilities Develop and execute quality strategies that align with Outset Medical's growth objectives, ensuring scalable manufacturing processes while prioritizing patient safety and regulatory compliance. Lead and mentor a team of quality professionals, fostering hands‑on collaboration, professional development, and a culture of accountability in daily operations. Oversee all QA functions at the manufacturing site, including incoming inspection, in‑process quality control, design transfer, non‑conformance (NC) management, Material Review Board (MRB), and Corrective and Preventive Action (CAPA) processes. Direct premarket quality activities, including risk management, verification and validation, and support for regulatory submissions, ensuring robust design transfer to manufacturing. Experiencia y requisitos Manage post‑market surveillance, including complaint trend analysis, root cause investigations, and continuous product improvements to enhance patient safety. Lead supplier quality programs, driving compliance and performance to support scalable production and reliable supply chains. Serve as the primary QA representative during regulatory inspections and audits, ensuring successful outcomes and effective communication with regulatory bodies (e.g., FDA, notified bodies). Collaborate within the global Quality function and cross‑functionally with Manufacturing, R&D (Hardware and Software), Regulatory Affairs, Supply Chain, and other departments to align quality objectives with operational and business goals. Develop and monitor key performance indicators (KPIs) for quality activities, such as defect rates, inspection efficiency, CAPA resolution times, and supplier performance, reporting progress and risks to senior leadership. Champion continuous improvement initiatives using Lean / Six Sigma methodologies to optimize manufacturing processes, enhance product quality, and support scalability. Qualifications Bachelor's degree in Engineering, Science, or a related technical discipline; advanced degree (e.g., MS, MBA) preferred. 10+ years of progressive quality leadership experience in the medical device industry, with at least 5 years in a manufacturing environment for Class II or Class III devices. Deep expertise in FDA 21 CFR Part 820, ISO , and related global regulatory standards, with a focus on patient safety and compliance. Proven track record of leading and mentoring diverse QA teams, with a hands‑on approach to coaching quality managers, engineers, technicians, and inspectors. Strong knowledge of manufacturing quality processes, including incoming inspection, design transfer, NC / CAPA management, MRB operations, and scalable production systems. Beneficios transporte Horario Tiempo completo Estudios Carrera con título profesional Inglés Hablado: Avanzado, Escrito: Avanzado Disponibilidad p. viajar Si Número de vacantes 1 Área Calidad Contrato Permanente Modalidad Presencial Turno Diurno Jornada Tiempo Completo #J-18808-Ljbffr
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Site Head, Quality
hace 3 semanas
Tijuana, México Outset Medical Mexico A tiempo completoPosition Overview The Site Head, Quality is a critical member of the senior leadership team at Outset Medical's Tijuana manufacturing site, responsible for overseeing the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO , and other global regulatory standards. This role drives quality excellence in the production of Class II...
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Head of Quality, Medical Devices
hace 3 semanas
Tijuana, México Outset Medical Mexico A tiempo completoUna empresa de dispositivos médicos busca un Site Head, Quality en Tijuana para liderar el sistema de gestión de calidad que asegure el cumplimiento de regulaciones. El candidato ideal debe tener más de 10 años de experiencia en liderazgo de calidad en la industria de dispositivos médicos y supervisar funciones de QA clave, incluida la formación de...
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Head of Quality, Medical Devices
hace 3 semanas
Tijuana, México Outset Medical Mexico A tiempo completoUna empresa de dispositivos médicos busca un Site Head, Quality en Tijuana para liderar el sistema de gestión de calidad que asegure el cumplimiento de regulaciones. El candidato ideal debe tener más de 10 años de experiencia en liderazgo de calidad en la industria de dispositivos médicos y supervisar funciones de QA clave, incluida la formación de...
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Site Head of Engineering Operations
hace 3 días
Tijuana, México Outset Medical A tiempo completo**Company Overview** Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally...
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Director of Quality
hace 1 semana
Tijuana, México Hillrom A tiempo completo**Director of Quality (QMR, Site Quality Leader Medical Device Manufacturing)** **-** ** ****Description**Currently we seek a Site Quality Leader and Director of Quality for the Tijuana manufacturing facility. S/he is the designated Quality Management Representative (QMR) for all aspects of Quality System implementation within that facility. This role...
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Director of Quality
hace 1 semana
Tijuana, México Hillrom A tiempo completo**Director of Quality (QMR, Site Quality Leader Medical Device Manufacturing)** **-** **22122566** **Description** Currently we seek a Site Quality Leader and Director of Quality for the Tijuana manufacturing facility. S/he is the designated Quality Management Representative (QMR) for all aspects of Quality System implementation within that facility. This...
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Quality Manager
hace 2 semanas
Tijuana, México Reckitt A tiempo completoThe Quality Manager operates in partnership with the Tijuana Site leadership, and as an active member of site’s Management Team.The primary responsibilities of the Quality Manager are to provide leadership for plant product quality and planning, facilitate quality improvement activities, assure proper quality systems are developed, implemented, and...
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Quality Systems Manager
hace 1 semana
Tijuana, México ICU Medical Tijuana A tiempo completoDescripción y detalle de las actividades Representative of the Quality Manager for the Tijuana Site before all Regulatory Agencies such as FDA, JPAL, CMDCAS, MDR, COFEPRIS and all those applicable to the Site. Essential **Responsibilities**: - Manages, plans, maintains and improves substantial regulatory compliance with applicable regulations. - Manages...
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Mgr Quality Ii
hace 1 semana
Tijuana, México Welbilt A tiempo completoDevelops and administers policies and procedures for evaluating and improving the quality of products, materials, components and/or manufacturing processes. Makes recommendations to ensure production runs meet established quality standards and predicted yields. Ensures employees follow established procedures and complete quality assurance work within time...
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Sr Quality Engineer
hace 3 semanas
Tijuana, México Resideo A tiempo completoBe a part of a team of Quality Engineers at the Tijuana Manufacturing Site that applies its expertise and knowledge in finding innovative, cost-effective means to improve quality output and continuous improvements. You will drive process initiatives that ensures compliance with customer requirements, regulatory agencies, government regulations and...
