Empleos de regulatory affairs en Tijuana

Descripción y detalle de las actividades The Quality Assurance and Regulatory Affairs Manager will drive the strategic and operational performance of the QA department, ensures the successful delivery of business strategy and operational goals to exceed customer expectations for product quality, customer service, engineering quality, cost and delivery, while facilitating continuous improvement...

The Quality Assurance and Regulatory Affairs Manager will drive the strategic and operational performance of the Quality department. This position ensures the successful delivery of business strategy and operational goals to exceed customer expectations for product quality, customer service, engineering quality, cost and delivery, while facilitating continuous improvement and achieving commercial...

Why Merit? En Merit Medical, nuestra misión es desarrollar dispositivos médicos innovadores que mejoren vidas. Nuestro objetivo es integrar y desarrollar a gente que quiere construir a través de trabajo duro, en equipo y comprometido, dispositivos que salvan vidas. Juntos estamos haciendo la diferencia en la vida de pacientes de todo el mundo. SUMMARY OF DUTIES Responsible for coordinating,...

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.Position OverviewThis position is responsible for...

Insulet started in **** with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are looking for highly motivated, performance...

**Vacancy Name** Junior Configuration Management Engineer. **Location of Work** Tijuana, Mexico **Employment Type** Full Time Employee **Our brand promise** **We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price. ** - **Remarkable service** **A seamless, personal process...

Our client is one of the fastest growing companies in the medical devices industry worldwide, recently recognized as one of the 50 Best Companies to Watch, and they have requested us to search for a Quality Director for their currently expanding manufacturing facility in Tijuana, B.C. ***: To ensure that all departments and suppliers are adhered to the requirements of laws and regulations...

Descripción y detalle de las actividadesCapability to design and develop custom test adapters and programs allows for more thorough and tailored testing of the medical cables. This ensures that the products meet specific requirements and standards, which is crucial for medical devices. Efficient testing processes developed by a competent Test Engineer can significantly reduce the time to market...

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...

Descripción y detalle de las actividades The Quality Engineer III will lead complex quality initiatives, support regulatory compliance, and drive continuous improvement efforts in a fast-paced maquiladora environment. This role is ideal for a seasoned quality professional with strong problem-solving skills and deep knowledge of medical device regulations. **Key Responsibilities**: - Lead and...

Summary: Monitors, coordinates and perform quality systems processes in order to sustain and improve quality systems, helping to increase quality of products and processes, consistent with established medical device industry standards and corporate objectives. - General Responsibilities _ - Supports to implement and maintain systems to ensure the measurement of progress towards key quality goals...

**What does Supplier Quality bring to Cardinal Health** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance,...

**Job Summary**: **Key Responsibilities**: **Validation & Compliance**: - Develop, execute, and maintain **Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)**protocols for manufacturing equipment, processes, and software. - Ensure compliance with **FDA 21 CFR Part 820, ISO *****, GMP, and GAMP 5**regulatory requirements. - Conduct **risk...

**Company Overview** Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of...

Why Merit? En Merit Medical, nuestra misión es desarrollar dispositivos médicos innovadores que mejoren vidas. Nuestro objetivo es integrar y desarrollar a gente que quiere construir a través de trabajo duro, en equipo y comprometido, dispositivos que salvan vidas. Juntos estamos haciendo la diferencia en la vida de pacientes de todo el mundo. ESSENTIAL FUNCTIONS PERFORMED 1. Determines global...

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.osition OverviewThis position is responsible for...

**Vacancy Name** Labeling Coordinator **Location of Work** Tijuana, Mexico **Employment Type** Full Time Employee **Our brand promise** We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price. - **Remarkable service** A seamless, personal process designed around you and your...

**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 simplifies it for providers. Tablo serves as a...

**Vacancy Name** - Document Control Coordinator **Location of Work** - Tijuana, Mexico **Employment Type** - Full Time Employee **Our brand promise** We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price. - **Remarkable service** A seamless, personal process designed around...