QA Engineer
hace 6 meses
International diagnostic and medical device company is looking for:
**QA Engineer**
As a Quality Engineer, you will manage and lead operations and continuous improvements of the company’s CAPAs and Supplier Management programs to ensure the best practices and compliance with federal and global regulatory requirements
**Essential Duties and Responsibilities**
- Manage the company’s CAPA process with focus on driving improvements in products and process performance.
- Coordinates and support activities for root cause investigations, and implementation of corrections and corrective actions, as well as evaluation of effectiveness of implemented changes.
- Facilitate cross functional team discussions in support of CAPA investigations and risk impact assessment report documents as per defined timelines Monitor CAPA KPIs, perform analysis, and interpret trends for process/product quality improvements.
- Provide training and coaching to employees authoring, reviewing, and approving CAPAs.
- Establish and maintain expert knowledge on quality system CAPA regulatory requirements in accordance with applicable FDA Regulations (21 CFR: Parts 820), and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization.
- Responsible for managing the day-to-day activities of the Approved Supplier List. This includes review and approval of all new suppliers or changes to existing suppliers.
- Qualify, manage, and monitor supplier performance per supplier management approved processes. Identify gaps in current processes to develop, define, establish, and document new processes, as needed.
- Monitor and ensure that required certifications, paper audits or site audits coming due for renewal are completed on time.
- Assuring all associated documentation is obtained, such as, Quality Agreements, Surveys, Quality System certifications.
- Collaborates with internal teams and suppliers to create new or modify existing Quality Agreements.
- Supplier Program
**Requirements**:
- BA/BS or equivalent in life science or engineering, or equivalent focus of study from an accredited university or college with 5-8 years relevant experience or typically 3-5 years with a Master’s degree in related field.
- Proficient knowledge of Quality Engineering policies, principles and best practices including quality standards: ISO 13485, 21CFR Part 820, ISO 14971, and other appropriate industry standards.
- Strong team player;
- Must be well organized, detail-oriented and able to maintain precise records;
- Ability to multi-task, prioritize and manage time effectively, while maintaining quality.
- MS Office (Word, Excel, PowerPoint, MS Project)
- Must have strong oral and written communication skills and computer skills.
- English fluency (Must)
Tipo de puesto: Tiempo completo
Horario:
- Diurno
Lugar de trabajo: Empleo presencial
-
QA Engineer A
hace 5 meses
Tijuana, México Corza Medical A tiempo completo**Vacancy Name** - QA Engineer A **Location of Work** - Tijuana, Mexico **Employment Type** - Full Time Employee - Controlar y mantener el sistema de calidad para cumplir con todos los requisitos reglamentarios aplicables, incluyendo los QSR de la FDA, ISO, Directiva de Dispositivos Médicos y otras normas y / o directrices aplicables. - Revisar los...
-
QA Automation
hace 6 meses
Tijuana, México Sequoia Connect A tiempo completo**Vacante para la empresa Sequoia Connect en Tijuana, Baja California**: Our Client is a leading Modernization and digital engineering Company. Our Client provides modernization services using its proprietary Platformation approach. It specializes in cloud and data modernization, Microsoft Dynamics Modernization, Digital contact center setup and management,...
-
QA Production Engineer
hace 5 meses
Tijuana, México North American Production Sharing A tiempo completo**QA Production Engineer (Medical Industry)** **Position Summary.** This position will assist with variety of QA related functions such as: DHR review and product release, Supplier Control, Equipment Asset control, Internal and External Audit Program and other Quality activities. **Essential Duties and Responsibilities** - Review and compile DHR's for...
-
QA Engineer
hace 6 meses
Tijuana, México Sensata Technologies A tiempo completoThe QA Engineer is responsible for making sure all products meet company and industry quality standards. Responsibilities also include designing and implementing tests, debugging and defining corrective actions. General Responsibilities - Organizes designs, implements and maintains quality assurance protocols and methods for processing materials into...
-
QA Production Engineer
hace 6 meses
Tijuana, México Emprego MX A tiempo completoDescripción y detalle de las actividades Job Functions - Review and compile DHR's for each lot of finished products to verify compliance with good documentation Practices, perform the final Quality release and generate COA. - Responsible for reviewing, approving, and releasing functional reports performed. - Manage database of the released lots and the...
-
QA Software Engineer
hace 6 meses
Tijuana, México Grupo Tress Internacional A tiempo completo**Grupo Tress Internacional**, líderes en Desarrollo de Software para la administración de Recursos Humanos, con más de 30 años en el mercado. **Objetivo**: Asegurar la calidad de las soluciones GTI mediante la detección y análisis oportuno de fallas y la elaboración de planes de calidad para los proyectos y soluciones...
-
Quality Assurance Software Engineer
hace 19 horas
Tijuana, Baja California, México Insulet Corporation A tiempo completoInsulet Corporation, the leader in tubeless insulin pump technology, is seeking a highly motivated Quality Assurance (QA) Software Engineer to join our expanding team. As a key member of our R&D department, you will play a critical role in ensuring the quality and reliability of our software products.About UsWe started in 2000 with a mission to enable...
-
QA Production Engineer
hace 5 meses
Tijuana, México North American Production Sharing de Mexico SA de CV A tiempo completo**Position Summary.** This position will assist with variety of QA related functions such as: DHR review and product release, Supplier Control, Equipment Asset control, Internal and External Audit Program and other Quality activities **Essential Duties and Responsibilities** - Review and compile DHR's for each lot of finished products to verify compliance...
-
QA Production Engineer
hace 6 meses
Tijuana, México North American Production Sharing A tiempo completo**Position Summary.** This position will assist with variety of QA related functions such as: DHR review and product release, Supplier Control, Equipment Asset control, Internal and External Audit Program and other Quality activities **Essential Duties and Responsibilities** - Review and compile DHR's for each lot of finished products to verify compliance...
-
Continuous Improvement QA Engineer
hace 3 semanas
Tijuana, México Sensata Technologies, Inc. A tiempo completoThe QA Engineer is responsible for making sure all products meet company and industry quality standards. Responsibilities also include designing and implementing tests, debugging and defining corrective actions. General Responsibilities - Coordinates designs, implements and maintains quality assurance protocols and methods for processing materials into...
-
Automation Testing Engineer
hace 4 semanas
Tijuana, Baja California, México Sequoia Connect A tiempo completoSequoia Connect is seeking a skilled Automation Testing Engineer to join its team in Tijuana, Baja California. The ideal candidate will have a strong background in software quality assurance and test automation, with experience in tools such as Selenium and Java.Key Responsibilities:Develop and maintain a comprehensive automation testing strategy, framework,...
-
Senior MongoDB Engineer
hace 2 semanas
Tijuana, Baja California, México AgileEngine A tiempo completoAbout the Role We are seeking a highly skilled Senior MongoDB Engineer to join our team at AgileEngine. As a MongoDB expert, you will be responsible for handling first-responder duties for support and alerts, ticket work such as provisioning, configuration, DDL, and DML, and supporting the Queue and Streaming team in various efforts to deliver cost...
-
AI-Enabled Cloud Solutions Software QA Engineer
hace 4 semanas
Tijuana, Baja California, México Thermo Fisher Scientific A tiempo completo**Meaningful Work at Thermo Fisher Scientific**At Thermo Fisher Scientific, we're dedicated to making a positive impact on a global scale. Our team is passionate about bringing our Mission to life every day, enabling our customers to make the world a better place.**Your Role in AI-Enabled Cloud Solutions**We're seeking a skilled Software QA Engineer to work...
-
Software Engineer with Proficiency in Python
hace 4 semanas
Tijuana, Baja California, México Unus Universidad A tiempo completoAs a software engineer at {company}, you will have the opportunity to work on a variety of projects that require proficiency in Python. Your primary responsibilities will include developing and maintaining software applications, as well as collaborating with cross-functional teams to ensure timely and efficient project delivery.Key responsibilities...
-
QA Engineer Mexico
hace 6 meses
Tijuana, México Prometeo Talent A tiempo completoPrometeo Talent is currently engaged in a strategic collaboration with a UK-based company that is embarking on a new chapter in Mexicothis exciting partnership, we are actively seeking a dynamic and skilled** Quality Automation Engineer** **to join the team. **Our Proposal** **It can be a perfect match if you meet**: - 2+ years of test automation...
-
Project Engineer
hace 5 meses
Tijuana, México Eddy Pump Corporation A tiempo completo,.,.**Job description** Eddy Pump is a fast-growing international engineering and manufacturing company. We are currently looking for an accountable project engineer to be responsible for all engineering and technical disciplines that projects involve. You will schedule, plan, forecast, resource, and manage all the technical activities aiming at assuring...
-
Test Engineer
hace 4 semanas
Tijuana, Baja California, México Skyworks Solutions A tiempo completoSkyworks is an innovator of high-performance analog semiconductors, powering the wireless networking revolution. We're looking for an experienced Test Engineer to join our team.As a Senior RF Test Engineer, you will be responsible for providing robust test solutions to NPI and Production teams. Your expertise will be focused on electronics measurements, RF...
-
Project Engineer
hace 6 meses
Tijuana, México Eddy Pump Corporation A tiempo completo,.,.**Job description** Eddy Pump is a fast-growing international engineering and manufacturing company. We are currently looking for an accountable project engineer to be responsible for all engineering and technical disciplines that projects involve. You will schedule, plan, forecast, resource, and manage all the technical activities aiming at assuring...
-
Software QA Leader
hace 6 meses
Tijuana, México Solar Turbines A tiempo completoCareer Area: Digital **Job Description**: Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about...
-
Quality Assurance Engineer II
hace 1 mes
Tijuana, Baja California, México Integer A tiempo completoAt Integer, our values are the foundation of our culture, driving us to create a unified and inclusive environment that fosters long-term success.We prioritize our customers' success, innovate to create better solutions, and collaborate to achieve success together.As a Quality Assurance Engineer II, you will play a crucial role in ensuring the quality of our...