Descripción y detalle de las actividades**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.Experiência 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 integral 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**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario**- Tiempo completo**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p.viajar** Si

📌 Site Head, Quality (Tijuana)
🏢 Outset Medical Mexico
📍 Tijuana