Quality Engineer
hace 1 día
- QA Engineer I that reports to HQ findings and compliance with healthcare product check and recheck data, administration data coming from production batches, analyzing, confirm product is correctly documented and assuring parts are OK in the QA/QC levels at 99% of the job-content.
- Carry out the review and approval of document changes, including procedures, work instructions, forms, and specifications, ensuring compliance with quality systems and good documentation practices in healthcare production.
- Monitor and control KPIs related to open MDRs (Material Discrepancy Reports), ensuring their follow-up, timely closure, and proper documentation
- Verify that the production, inspection, and test records are complete, accurate, and traceable.
- Participate in the identification and analysis of non-conformities, supporting corrective and preventive actions (CAPA).
- Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information.
- Review Design History Files (DHF) for accuracy and compliance to internal and regulatory (FDA) requirements.
- Generate statistical reports on quality performance in the process and in the product: Review quality data trending to determine if action(s) need to take place.
- Execute CAPA (Corrective and Preventive Action) tools as required, to bring about the desired changes and continuous improvement.
Experiencia y requisitos
- Industrial Engineer or related
- 2 to 3 years of experience in quality systems.
- Strong Communication Skills (both written and verbal) Advanced English (MIN 80%)
- Knowledge of quality systems: ISO 13485
- Experience with CAPA, required.
- Knowledge of methodologies: Lean Manufacturing, APQP, FMEA, SPC
- Strong knowledge of computer database Excel.
- Strong aptitude for problem solving root cause analyses.
- Experience in monitoring non-conformities and corrective actions.
Beneficios
- Beneficios de acuerdo a la LFT
- Bono Asistencia, Puntualidad yTransporte
- Vale despensa
Número de vacantes 1
Área Calidad
Contrato Permanente
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
Horario
- Lunes a Jueves 7:30am a 6pm Viernes 7:30am a 3:30pm
Estudios Carrera sin título
Inglés Hablado: Avanzado, Escrito: Intermedio
Disponibilidad p. viajar No
-
Quality Engineer
hace 6 días
Tijuana, B.C., México NME150126RVA A tiempo completoResponsible to ensure that products released at the different production stages meet all predetermined requirements, and production activities are performed in regulatory compliance per FDA 21 CFR part 820 and ISO 13485:2016. Contributes and participates in the activities required to achieve the quality performance metrics and guarantee the continuous...
-
Sr Quality Engineer
hace 6 días
Tijuana, B.C., México Schlage De México, S.A. De C.V. A tiempo completoy detalle de las actividadesOBJECTIVE:Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize...
-
Quality Engineer
hace 1 semana
Tijuana, B.C., México Flex LTD A tiempo completoFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every...
-
Quality Engineer
hace 1 semana
Tijuana, México Carlisle Medical Technologies A tiempo completoDescripción y detalle de las actividades Quality Engineer I is responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of quality control measures, and identification of areas for improvement, collaborates with cross-functional teams to address quality issues, drive continuous improvement,...
-
Quality Engineer
hace 1 semana
Tijuana, México Carlisle Medical Technologies A tiempo completoDescripción y detalle de las actividadesQuality Engineer I is responsible for ensuring the safety and quality of our products and procedures through rigorous inspections, implementation of quality control measures, and identification of areas for improvement, collaborates with cross-functional teams to address quality issues, drive continuous improvement,...
-
Quality Engineer
hace 1 semana
Tijuana, México North American Production Sharing A tiempo completoWe are looking for a Quality Engineer to join our high growth organization who will work with multidisciplinary teams to always strive to ensure that the quality of the products meet our specification and support the Voice of the Customer. When non-conformance are found the QA Engineer must act with urgency to quickly and effectively collect data, working...
-
Supplier Quality Engineer
hace 2 semanas
Tijuana, B.C., México Flex A tiempo completoFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every...
-
Quality Engineer
hace 4 días
Tijuana, México North American Production Sharing A tiempo completoCompany dedicated to performing medical assemblies located in the Pacific area is looking for a Quality Engineer: **Position Summary** This position will assist with the ongoing monitoring, support, and continued improvement of QA Production processes and related activities and conduct periodic audits to ensure compliance and controls of the production...
-
Sr. Quality Engineer
hace 1 semana
Tijuana, México Ensambles Hyson, S.A. de C.V. A tiempo completoDescripción y detalle de las actividadesOverview The Sr. Quality Engineer will be responsible to provide quality support and the development of manufacturing processes for molding areas. Responsibilities This individual will be responsible to provide quality support and the development of manufacturing processes for molding areas. The engineer will use...
-
Quality Engineer
hace 1 día
Tijuana, México Grupo TECMA A tiempo completoDescripción y detalle de las actividades - Manage all quality-related issues within the manufacturing team (e.g. internal, supplier, customer, and customer warranty) - Identify root cause and instigate permanent corrective actions for product quality issues. - Carry out product and process auditing. - Ensure control plans and associated documentation are...