Manager Quality Assurance Complaint Lab

hace 2 semanas


Tijuana, México Emprego MX A tiempo completo

Descripción y detalle de las actividades

Responsible for investigational activities relating to infusion pumps and monitoring devices. This role manages a team of engineers and technicians and is responsible for the development, implementation, and maintenance of processes associated with complaint investigations requiring failure analysis of returned infusion systems and component parts from servicing operations. This individual will be responsible for the integrity of the investigations and ensure investigation conclusions are clear, supported, robust, and compliant. This individual will establish best practices in investigation failure analysis processes for large volumes of complaints and associated root cause determination, including inspection, test protocols and methodologies. - Develops, implements, and maintains complaint investigation failure analysis processes including writing requirements, process documentation, inspection and test protocols for systems, modules and component parts. -Design, purchase and release of investigation test fixtures for failure analysis lab. This may also include leading and performing IQ/OQ/PQ test fixture verification activities that business process deems necessary. -Ability to solve complex problems by developing investigation test methodologies, processes & training materials. -Serve as a Subject Matter Expert for failure analyses that includes both internal functional support and external customer support with respect to analysis findings and associated improvements initiatives. -Perform remediation of complaint process as part of on-going FDA compliance activities & 483 corrective actions. -Own and/or lead investigations & root cause analysis efforts for Corrective and Preventive Actions (CAPAs) when necessary. Support CAPA investigations by R&D and Operations where field return analyses may assist in those CAPA investigations. Support, and provide input to, monthly complaint trend reviews and resulting CAPA triggers. -Develop, compile and present complaint investigation and failure analysis summary metrics to Senior and Executive Management, as necessary

Experiência y requisitos
- BS/BA in engineering discipline or equivalent experience with lab -Experience leading a Failure Investigation team -Professional certification is a plus; e.g. Six Sigma Green Belt, etc. -Minimum of 7 years of experience in failure analysis, manufacturing operations, servicing, and/or R&D activities leading investigation teams or designing inspections and tests for complex electro-mechanical equipment. -Demonstrated history of effective root cause determination in complex electro-mechanical, software-driven medical devices. -Must possess ability to establish new failure investigation processes, test protocols, and procedures and to build a team performing these activities. -Specific knowledge of infusion pump is preferred

Organización

Sistemas Médicos Alaris (BD) planta EMI

Correo de contacto

Giro

Maquiladora (Export.)

Actividad principal

Empresa internacional de tecnología médica.

Número de empleados

1000

**Área** Calidad

**Contrato** Permanente

**Turno** Diurno

**Jornada** Tiempo Completo

**Estudios** Titulo Profesional

**Inglés **Hablado: 95%, Escrito: 95%

**Sexo** Indistinto



  • Tijuana, B.C., México Prodensa A tiempo completo

    Responsible for delivering optimum quality of a company’s services or goods. In addition to maintaining consistent quality, they help to ensure compliance with laws, regulations, and environmental standards, recommending improvements where necessary. Creates and implements company quality standards. Accomplishes quality assurance objectives by...


  • Tijuana, México WS Audiology A tiempo completo

    Descripción y detalle de las actividades - Part of the DCU working in Global and multicultural Team that assures customer complaints are captured, assessed for reportability, processed and resolved in a timely matter as per applicable internal and regulatory requirements. To provide input, carry on Global Projects and improvements related to complaint...

  • Quality Assurance Lead

    hace 3 días


    Tijuana, México Trevé A tiempo completo

    **Summary**: QA Lead ensures product quality and timely delivery by overseeing post-hand-off processes from Product Development. Coordinates with China Production Team, enforces quality control, manages testing, and resolves production issues. **General Responsibilities**: - Collaborate with cross-functional teams for vendor allocation recommendations. -...


  • Tijuana, México WSAudiology A tiempo completo

    [a few high level lines to describe the mission of the role]What you will doPart of the DCU working in Global and multicultural Team that assures customer complaints are captured, assessed for reportability, processed and resolved in a timely matter as per applicable internal and regulatory requirements. To provide input, carry on Global Projects and...

  • Quality Manager

    hace 3 semanas


    Tijuana, Baja California, México Eaton A tiempo completo

    Eaton's IS AER FED division is currently seeking a Quality Manager.What You'll DoJob Summary The Quality Manager plays a crucial role in defining, executing, and implementing the Strategic Quality Plan, Goals, and Objectives at the operational level. They work closely with plant quality teams and represent group management for the Quality management system....

  • Complaint Device Engineer

    hace 4 semanas


    Tijuana, México Emprego MX A tiempo completo

    **Descripción y detalle de las actividades** - Complaint Device Investigation: - Handling of 1st/2nd level customer complaint device investigations to ensure timely resolution of a customer reported issue. Ensure appropriate documentation of the investigation in the complaint file and escalation of issues to other groups as necessary. Responsible for...

  • Quality Supervisor

    hace 4 semanas


    Tijuana, México Eaton A tiempo completo

    **What you’ll do**: **Primary Function**: Executing the defined Strategic Quality Plan in conjunction with plant leadership in Tijuana Mexico. Under the leadership of a QA Manager, works closely with current Eaton Product transitions sites to ensure all quality requirements are met for production. This position would lead Quality process team utilizing...

  • Quality Manager

    hace 3 semanas


    Tijuana, B.C., México Eaton Corporation A tiempo completo

    Eaton’s IS AER FED division is currently seeking a Quality Manager. What you’ll do: Job Summary The Quality Manager plays a crucial role in defining, executing, and implementing the Strategic Quality Plan, Goals, and Objectives at the operational level. They work closely with plant quality teams and represent group management for the Quality...

  • Quality Assurance Manager

    hace 4 semanas


    Tijuana, México Emprego MX A tiempo completo

    Descripción y detalle de las actividades Job description Summary: Develop Quality strategies that help improve our customers' experience. Monitor and lead activities of the Quality analyst team responsible for monitoring, feedback and calibration activities. Analyze and generate reports that translate into process improvement and KPIs. Responsibilities:...


  • Tijuana, B.C., México Schneider Electric Gruppe A tiempo completo

    Job Description - Manufacturing Quality Assurance Engineer (008T0Q) Manufacturing Quality Assurance Engineer - 008T0Q Mission • Identify non-quality factors continuously, conduct or have other departments conduct in-depth analyses and monitor quality improvement plans. • Identify potential issues before they occur and implement preventive solutions....

  • Quality Supervisor

    hace 4 semanas


    Tijuana, México AR Consultoria RH A tiempo completo

    _**Core Responsibilities & Duties.**_ - Maintain Quality Management Systems - Facilitate and coach Corrective Actions to Automotive Customer; Manage the Customers’ relationship. - Management Reviews and Business Objective Progress Reporting - Ensure Customer Specific Quality Requirements are adhered to in each production process. - Where necessary define...


  • Tijuana, México Emprego MX A tiempo completo

    **Descripción y detalle de las actividades** - The Quality Control manager directs the activities of the quality control team, ensuring the team members work accurately and effectively to bring quality services for the company and customers. Plan, coordinate, and direct the Quality Control program activities designed to ensure continuous production....

  • Quality Manager

    hace 4 semanas


    Tijuana, México OPTIMA ORGANIZATIONAL SOLUTIONS A tiempo completo

    **GENERAL FUNCTION** The Quality Manager partners with facility plant leaders to lead the quality function and quality results at the logistics/distribution facility. Through in-depth data analysis, root cause analysis and problem solving tools (Six Sigma methodology) and collaboration with key functions such as engineering, operations, training and...


  • Tijuana, México Cellular Performance Institute A tiempo completo

    **World renowned Cellular Performance Institute looking for Quality Management System Manager** The Cellular Performance Institute, located in Playas de Tijuana, is looking for a Quality Management System Manager responsible for developing, implementing, and maintaining our Quality Management System (QMS) to ensure compliance with regulatory requirements...

  • Quality Assurance Analyst

    hace 4 semanas


    Tijuana, México HYUMAN A tiempo completo

    In this role, you will support to develop and shape Axos Bank’s fromtline support strategy and execution. You will work closely with the call center leadership team, internal, and cross functional stakeholders. **Duties/Responsibilities**: - Maintains and develops internal quality standards. - Analyze NPS and CSAT results and provide constructive...


  • Tijuana, México Stryker Corporation A tiempo completo

    **Who we want** - ** Compliance-focused orchestrators.** Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures. - ** Managers who drive performance.** People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity. -...


  • Tijuana, Baja California, México Schneider Electric A tiempo completo

    Manufacturing Quality Assurance Engineer-008TNYSchneider Electric esta buscando un INGENIERO DE CALIDAD en CIUDAD, Tijuana B.C Mission• Identify non-quality factors continuously, conduct or have other departments conduct in-depth analyses and monitor quality improvement plans.• Identify potential issues before they occur and implement preventive...

  • Quality Engineer

    hace 4 semanas


    Tijuana, México Emprego MX A tiempo completo

    **Descripción y detalle de las actividades** - Quality Assurance - Analysis of customer data (Complaints/Issues). Reviewing, auditing processes. Audit the correct methods of inspection of materials and processes through the use of approved procedures to ensure their quality in all stages of manufacturing. Surveillance of calibrated equipment and calibration...

  • Quality Manager

    hace 4 semanas


    Tijuana, México Emprego MX A tiempo completo

    Descripción y detalle de las actividades GENERAL FUNCTION The Quality Manager partners with facility plant leaders to lead the quality function and quality results at the logistics/distribution facility. Through in-depth data analysis, root cause analysis and problem solving tools (six sigma methodology) and collaboration with key functions such as...


  • Tijuana, Baja California, México Schneider Electric A tiempo completo

    Schneider Electric esta buscando un INGENIERO DE CALIDAD en CIUDAD, Tijuana B.CMission Identify non-quality factors continuously, conduct or have other departments conduct in-depth analyses and monitor quality improvement plans. Identify potential issues before they occur and implement preventive solutions. Solve quality manufacturing issues affecting...