Sr. Quality Systems Engineer
hace 9 horas
Descripción y 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 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.Experiência y requisitosBacherlor Degree in engineeering or equivalent.Minimum of 3-5 years of experience in Medical Device Quality SystemsExperience in internal/external auditsENGLISH 90% WRITTEN/SPOKENKnowleadge of ISO13485, MDSAP & FDA 21CFR820Problem-Solving SkillsCertified as an Internal Auditor (Preferably)- 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.- Interface with complaint corporate department the review of customer complaints.- Provide leadership and follow up with team members on customer complaint investigations.- Ensure the integrity of the QMS thru the Corrective and Preventive Action (CAPA) program.- Coordinate the CAPA system and monitor the process of improvement.- Generate Trend Analysis Reports for Corporate Quality Management Reviews.- Auditor Leader for the QMS audit program.- Facilitate and support external audits from customer and third parties, including tracking and follow-up on audit findings.- Supports the environmental monitoring process of the cleanroom and prepares results reports.- 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.Beneficios- Beneficios de acuerdo a la LFT**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Salario mensual neto** $1,000 - $1,001 MXN**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p. viajar** No
-
Sr Quality Systems Engineer
hace 7 días
Mexicali, México Emprego MX A tiempo completo**Descripción y detalle de las actividades** - Sensata Technologies is a global industrial technology company striving to create a cleaner, more efficient, electrified and connected world. Through our broad portfolio of sensors, electrical protection components and sensor-rich solutions which create valuable business insights, we help our customers address...
-
Sr. Quality Systems Engineer
hace 2 días
Mexicali, México Medline A tiempo completoDescripción y detalle de las actividades 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...
-
Sr. Quality Systems Analyst
hace 3 semanas
Mexicali, 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 días
Mexicali, México Mam de la Frontera, S.A. de C.V. A tiempo completoMicrometals MexicaliMicrometals has been a leading global manufacturer of inductor cores for over 65 years. Micrometals cores are found in thousands of applications around the world, from the most cutting-edge flat-screen TVs to power conditioning systems, to electric vehicles, to the engines that power offshore oil rigs.The Quality Engineer is a hybrid...
-
Sr Quality Engineer
hace 2 horas
Mexicali, México Mam de la Frontera, S.A. de C.V. A tiempo completoMicrometals MexicaliMicrometals has been a leading global manufacturer of inductor cores for over 65 years. Micrometals cores are found in thousands of applications around the world, from the most cutting-edge flat-screen TVs to power conditioning systems, to electric vehicles, to the engines that power offshore oil rigs.The Quality Engineer is a hybrid...
-
Quality Sr Engineer
hace 6 días
Mexicali, 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...
-
Sr. Customer Quality Engineer
hace 2 semanas
Mexicali, México Emprego MX A tiempo completoDescripción 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...
-
Sr Quality Engineer
hace 7 días
Mexicali, México Advanced Energy Industries, Inc A tiempo completoSR QUALITY ENGINEER **ESSENTIAL FUNCTIONS**: - Engage in new product release process and ensure that quality system effectiveness have been validated to ensure quality goals are fully achieved at the time of product release. - Ensure that an appropriate quality plan is created and executed for new product launches and intercompany product transfers,...
-
Sr. Quality Engineer
hace 2 días
Mexicali, México Ascotech, S.A. de C.V. A tiempo completoDescripción y detalle de las actividades The Sr. Quality Engineer establishes, maintains, and improves all areas of the Quality System to ensure that manufacturing processes are controlled and regularly reviewed, analyzed, and reported in an effort to contribute to continuous improvement within production facilities. **In This Role, Your Responsibilities...
-
Sr. Quality Engineer
hace 9 horas
Mexicali, México Ascotech, S.A. de C.V. A tiempo completoDescripción y detalle de las actividadesThe Sr. Quality Engineer establishes, maintains, and improves all areas of the Quality System to ensure that manufacturing processes are controlled and regularly reviewed, analyzed, and reported in an effort to contribute to continuous improvement within production facilities.**In This Role, Your Responsibilities Will...
