Sr. Quality Systems Engineer
hace 2 semanas
The Sr. Quality Systems Engineer is the responsible in the development, implementation and follow up of the QMS (MDSAP, ISO13485 & FDA 21CFR Part 820) for MXC ensuring compliance to the applicable standards and regulations for the medical devices.
Develop the internal audit program in MXC.
Acts as Auditor Leader during Corporate Internal Audits, FDA, BSI and Customer Audits across all areas of the business.
Responsible for managing the Document Control activities through the EtQ Reliance system to ensure its effectiveness.
Coordinate and follow up the CAPA system.
Coordinate customer complaints investigations and communicate them to team members.
Lead quality projects improvements based on quality data trends.
This position requires strong knowledge in Quality Systems Standards and Regulations (MDSAP, ISO13485, MDSAP & FDA 21 CFR Part 820) in the medical device manufacturing environment.
- Assure compliance of all applicable Quality System Standards and Regulations (MDSAP, ISO13485, MDSAP & FDA 21CFR Part 820).
- Perform gap assessment to the QMS.
- Implement and maintain Quality Management System and related documentation and procedures for MXC as required.
- Support the goals and objectives of the organization within the Mexicali facility.
- Revise QA complaints in SAP module.
(desirable) - Interface with complaint corporate department the review of customer complaints - Lead and support quality process improvement projects.
- Maintain the Quality Scorecard updated as required.
- Provide training to new employees on the Quality System and EtQ Reliance.
- Support in the planning and execution of the Quality Week activities.
- Participate in the different programs of the organization as required.
Experiência y requisitos
Bachelor's Degree: Engineering, or an equivalent 3-5 years of experience in Medical Device Quality Systems English fluid 85-90%) Experience in Internal/External Audits Knowledge of ISO13485, MDSAP & FDA 21CFR820 Problem-Solving Skills Certified as an Internal Auditor (Preferably) Office Windows: Word, Excel, Power Point, etc.
ETQ Reliance, AS400 ERP Systems (AS400, SAP).
Desirable Communication Teamwork Proactive Results Oriented Sense of urgency Organized Responsible
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario** Lunes a viernes de 8:00 a.m. a 5:00 p.m.
**Estudios** Carrera Profesional
**Sexo** Indistinto
**Disponibilidad p. viajar** No
-
Sr. Quality Systems Engineer
hace 3 semanas
Mexicali, Baja California, México Medline A tiempo completoy detalle de las actividadesThe Sr. Quality Systems Engineer is the responsible in the development, implementation and follow up of the QMS (MDSAP, ISO13485 & FDA 21CFR Part 820) for MXC ensuring compliance to the applicable standards and regulations for the medical devices.Develop the internal audit program in MXC.Acts as Auditor Leader during Corporate...
-
Sr. Quality Systems Analyst
hace 2 semanas
Mexicali, Baja California, México Skyworks A tiempo completoIf you are looking for a challenging and exciting career in the world of technology, then look no further.Skyworks is an innovator of high performance analog semiconductors whose solutions are powering the wireless networking revolution.At Skyworks, you will find a fast-paced environment with a strong focus on global collaboration, mínimal layers of...
-
Jr. Quality Engineer
hace 2 semanas
Mexicali, Baja California, México Buscojobs México A tiempo completoy detalle de las actividades- Supports Sr Customer Quality Engineer to track, measure and report Customer Claims - Supports the efforts and continuous improvement projects for the KPIs of the Quality department.- Supports Sr Customer Quality Engineer in activities related to RMA Process - Supports on Warranty analysis reports working with warranty technician...
-
Quality Sr Engineer
hace 4 semanas
Mexicali, Baja California, México Medline Industries A tiempo completoQuality Sr Engineer **Job Number**:QUA0101IB )**Primary Location **: Mexico-Baja California Norte-Mexicali**Description**:The Senior Quality Engineer executes and coordinates Quality Engineering functions with a focus on continuous improvement of sterile and non sterile products and processes for MXC site.Leads the execution of initiatives and projects to...
-
Sr. Customer Quality Engineer
hace 7 días
Mexicali, Baja California, México Buscojobs México A tiempo completo**Descripción y detalle de las actividades**- Oversees and/or performs Quality activities oriented to assure Customer Satisfaction.Will have direct & frequent contact with customer and/or internal/external cross-functional team impact as requested.Lead & Support Projects related to Get Customer Certifications for the plant, is going to be the driver of the...
-
Quality Systems Engineer
hace 2 semanas
Mexicali, Baja California, México Buscojobs México A tiempo completoy detalle de las actividadesMaintain the Quality Manuals and Quality Procedures and ensure contents are appropriate for business Organize and manage the plant internal audit system and the corrective action reporting system Conduct/experience in performing Quality systems audits and assist in training/guidance to other auditors Host and plan external Quality...
-
Quality Systems Engineer
hace 2 semanas
Mexicali, Baja California, México Buscojobs México A tiempo completoy detalle de las actividadesMaintain the Quality Manuals and Quality Procedures and ensure contents are appropriate for business Organize and manage the plant internal audit system and the corrective action reporting system Conduct/experience in performing Quality systems audits and assist in training/guidance to other auditors Host and plan external Quality...
-
Quality Engineer 2
hace 2 semanas
Mexicali, Baja California, México Skyworks A tiempo completoSi estás buscando una carrera desafiante y emocionante en el mundo de la tecnología, no busques más.Skyworks es una empresa innovadora de semiconductores análogos de alto rendimiento cuyas soluciones están impulsando la revolución de redes inalámbricas.En Skyworks, encontrarás un entorno acelerado con un gran enfoque en la colaboración global,...
-
Industrial Quality Engineer
hace 1 día
Mexicali, Baja California, México Collins Aerospace A tiempo completo**About the Role**We are seeking an experienced Industrial Quality Engineer to join our team. As an Industrial Quality Engineer, you will be responsible for developing and implementing quality systems, procedures, and processes to ensure compliance with regulatory requirements and company standards.**Key Responsibilities**- Develop and implement quality...
-
Quality Systems Engineer
hace 4 semanas
Mexicali, Baja California, México Buscojobs México A tiempo completoy detalle de las actividadesKey Responsibilities: System throughout the company, including any business accreditations -Maintain the Quality Manuals and Quality Procedures and ensure contents are appropriate for business - Organize and manage the plant internal audit system and the corrective action reporting system - Conduct Quality Systems audits and...
-
Quality Systems Engineer
hace 4 semanas
Mexicali, Baja California, México Buscojobs México A tiempo completoy detalle de las actividadesKey Responsibilities: System throughout the company, including any business accreditations -Maintain the Quality Manuals and Quality Procedures and ensure contents are appropriate for business - Organize and manage the plant internal audit system and the corrective action reporting system - Conduct Quality Systems audits and...
-
Sr. Quality Engineer
hace 2 semanas
Mexicali, Baja California, México Buscojobs México A tiempo completoy detalle de las actividadesJob Purpose: Support and assist the Sr Quality Assurance Manager and Quality Engineers in maintaining a highly compliant quality management system with a strong focus on customer complaints and coordinating and executing quality inspections and process audits.Responsible for Quality oversight and support for QC and Operation...
-
Sr Quality Engineer
hace 2 semanas
Mexicali, Baja California, México Garrett Advancing Motion A tiempo completoy detalle de las actividadesOversees and/or performs quality activities for a customer(s), a process/cell or work unit, or a commodity or set of suppliers.Direct impact to customer satisfaction, product quality and Cost of Poor Quality.Depending on role, will have direct & frequent customer contact, supplier contact and/or internal cross-functional impact.-...
-
Senior Quality Engineer Lead
hace 3 días
Mexicali, Baja California, México Medline Industries, LP A tiempo completoAbout the RoleThis Senior Quality Engineer Lead position is ideal for individuals who have experience in implementing and maintaining quality management systems. You will lead cross-functional teams to drive process improvements and ensure regulatory compliance.
-
Quality Engineer
hace 3 semanas
Mexicali, Baja California, México Footprint A tiempo completo**Responsibilities**:- Set detailed guidelines on what needs to be checked and what the quality standards are- Update our Quality Management System (QMS) with incidents, fixes and improvements- Audit our systems based on ISO 9001:2015 requirements- Determine quality metrics for all manufacturing procedures- Monitor the entire production cycle and perform...
-
Sr Quality Engineer
hace 3 semanas
Mexicali, Baja California, México Intuitive A tiempo completo**Company Description**: Descripción de la empresaEn Intuitive, estamos unidos detrás de nuestra misión: creemos que la atención mínimamente invasiva es la atención que mejora la vida.Mediante la inventiva y la tecnología inteligente, ampliamos el potencial de los médicos para curar sin limitaciones.Como pioneros y líderes del mercado en cirugía...
-
Sr. Design Engineer
hace 6 días
Mexicali, Baja California, México Collins Aerospace A tiempo completoThe Sr. Design Engineer will work within the Structures Engineering organization as part of a product development team to design and develop structural components and systems for aircraft nacelles or auxiliary components.They will perform detail design and assembly work, configuration control, and create drawings and model-based definition using CATIA V5...
-
Quality Systems Analyst 2
hace 3 semanas
Mexicali, Baja California, México Skyworks A tiempo completoIf you are looking for a challenging and exciting career in the world of technology, then look no further.Skyworks is an innovator of high performance analog semiconductors whose solutions are powering the wireless networking revolution.At Skyworks, you will find a fast-paced environment with a strong focus on global collaboration, mínimal layers of...
-
Sr. Quality Engineer
hace 2 semanas
Mexicali, Baja California, México Emermex, S.A. De C.V. A tiempo completoy detalle de las actividades- Under the direction of the Quality Engineering Manager, performs the various technical duties of quality control and quality assurance, such as but not limited to, establishing inspection procedures and methods, adopting SPC programs and educating associates in their uses, assuring Quality product in new products and lines at...
-
Sr Design Engineer
hace 3 semanas
Mexicali, Baja California, México Garrett Advancing Motion A tiempo completoGarrett Advancing Motion is looking for a **Senior Design Engineer **to support the development of cutting-edge new products to meet ever increasing demands of the transportation industry.This position requires a broad understanding of turbochargers & vehicle systems combined with creativity and drive to develop new products based on customer...