Manager, QA Compliance

hace 6 meses


Heredia, Costa Rica AbbVie A tiempo completo

**Company Description**

Supervisar el Laboratorio de Análisis de Quejas (DAL) y los departamentos de Revisión de Documentos (DHR), auditorías internas/externas y CAPA en Costa Rica con el objetivo de asegurar un funcionamiento eficiente y efectivo de los diferentes procesos y servicios que se brindan por medio de la realización oportuna de las tareas y cumpliendo con los lineamientos del Sistema de Calidad y entes regulatorios.
- Establecer, dirigir y coordinar los objetivos departamentales, métricas y sistemas departamentales, así como resolver conflictos y trabajar en coordinación con otros departamentos para asegurar el cumplimiento de los objetivos de la compañía
- Administrar el proceso de revisión de los DHR e investigaciones (FI) correspondientes a la manufactura de dispositivos médicos. Asegurar el cumplimiento de los requisitos regulatorios aplicables, los requisitos establecidos por el departamento de “Product Surveillance” y a su vez proveer información relevante al proceso productivo de dichos resultados.
- Administrar el proceso para el análisis de quejas recibidas por clientes externos correspondientes a la manufactura de “breast implants”. Asegurar el cumplimiento de los requisitos regulatorios aplicables y los requisitos establecidos por los clientes internos (Product Surveillance) y externos.
- Promover y apoyar iniciativas de mejora continua relacionadas a los procesos a cargo o introducción de nuevos productos con el objetivo de identificar y coordinar actividades requeridas propias de las áreas.
- Administrar el proceso de NCRs (CAPA) cumpliendo con los plazos y métricas establecidas por la compañía.
- Liderar el programa de auditoría interna del Sistema de Calidad de la planta, y asegurar la ejecución del mismo.
- Liderar la preparación y ejecución de las auditorías o inspecciones externas al Sistema de Calidad de la planta, organizando los recursos y documentación necesarios para una adecuada reacción a dichas auditorías o inspecciones.
- Cumplir con las demás funciones inherentes al cargo y aquellas asignadas por su jefe inmediato.
- Velar por la motivación de los colaboradores de las áreas asegurando que se refuerzan y reconocen oportunamente, de manera formal e informal, los comportamientos que promueve la cultura Abbvie.
- Definir y controlar el presupuesto de las áreas a cargo.
- Garantizar el cumplimiento de los requerimientos corporativos y legales de EHS, mediante el acatamiento de la política y los procedimientos internos. Así mismo, garantizar el cumplimiento mediante la adopción de estrategias, controles internos comunicación y entrenamientos necesarios.
- Mejorar continuamente los resultados de EHS a través del liderazgo, el compromiso y la participación activa en todas las iniciativas relacionadas con EHS.
- Liderar el programa de auditoría interna del Sistema de Calidad de la planta, y asegurar la ejecución del mismo.
- Liderar la preparación y ejecución de las auditorías o inspecciones externas al Sistema de Calidad de la planta, organizando los recursos y documentación necesarios para una adecuada reacción a dichas auditorías o inspecciones.
- Cumplir con las demás funciones inherentes al cargo y aquellas asignadas por su jefe inmediato
- Velar por la motivación de los colaboradores de las áreas asegurando que se refuerzan y reconocen oportunamente, de manera formal e informal, los comportamientos que promueve la cultura Abbvie.
- Definir y controlar el presupuesto de las áreas a cargo.
- Garantizar el cumplimiento de los requerimientos corporativos y legales de EHS, mediante el acatamiento de la política y los procedimientos internos. Así mismo, garantizar el cumplimiento mediante la adopción de estrategias, controles internos comunicación y entrenamientos necesarios.
- Mejorar continuamente los resultados de EHS a través del liderazgo, el compromiso y la participación activa en todas las iniciativas relacionadas con EHS.

**Qualifications**
- Bachillerato en Ingeniería Industrial, Administración de Empresas o carrera afín.
- Experiência de al menos 5 años en posiciones relacionadas dentro del sistema de calidad y deseable experiência en manejo de quejas en industria médica.
- Experiência de al menos 3 años en supervisión de personal.
- Manejo de Sistemas de Gestión de Calidad de dispositivos médicos ISO 13485:2016.
- Participación previa en auditorías de Calidad, preferiblemente del FDA o algún ente certificador de las normas ISO.
- Dominio de herramientas Lean como Value Stream Mapping, SMED, DMAIC.
- Nível B2 inglés.

**Deseable**
- Al menos un 50% de avance de la Maestría en carrera afín.
- Facilidad para el trabajo con programas en ambiente Windows, tales como Word, Power Point, Visio.
- Entrenamientos/certificaciones en las siguientes regulaciones:

- CMDR (Opcional)
- MHLW Ministerial Ordinance No. 169,2004 (Opcional)
- Medical Device Single Audit Program (MDSAP)
- FDA Inspections


  • Senior QA Analyst

    hace 6 meses


    Heredia, Costa Rica SGF Global A tiempo completo

    **Senior QA Analyst (Hybrid)** **Heredia, Costa Rica** SGF Global is looking for a Senior QA Analyst, for IT enterprise in Heredia, Costa Rica. **Requirements**: - University degree in IT, Computer Science or equivalent experience. - 5+ years successfully working as QA/Testing Analyst, Test Lead, Business System Analyst or related experience. -...

  • Senior QA Analyst

    hace 6 meses


    Heredia, Costa Rica NTT DATA A tiempo completo

    **Req ID**: 275516 We are currently seeking a Senior QA Analyst to join our team in Heredia, Heredia (CR-H), Costa Rica (CR). **Senior QA Analyst** **JOB PURPOSE AND IMPACT** **KEY ACCOUNTABILITIES** - Coordinates the test activities for SIT, UAT, Regression, in coordination with Project Manager and Business Analyst when required - Prepares status updates...

  • Software QA Analyst

    hace 7 meses


    Heredia, Costa Rica Straumann Group A tiempo completo

    **#ChangeMakers** **Ready to make an impact?** We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. We empower our employees to perform and make an impact, to question the status quo, to...

  • QA Automation Engineer

    hace 6 meses


    Heredia, Costa Rica Firmex A tiempo completo

    Firmex, a Datasite company, is a global software-as-a-service provider. The company’s Firmex VDR service is the world’s most trusted virtual data room, having been used by over 140,000 companies worldwide to share confidential documents for due diligence, litigation and compliance. This is a rare opportunity to have a significant say and impact on the...


  • Heredia, Costa Rica Amazon Support Services Costa Rica SRL - B20 A tiempo completo

    3+ years experience in program or project management - Experience using data and metrics to drive improvements - Experience defining requirements, facilitating progress and identifying blockers. - Experience implementing repeatable processes and driving automation or standardization - Experience owning program strategy and end to end delivery - Experience...


  • Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Remote in Country**Onsite Location(s)**:Heredia, H, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some...


  • Heredia, Costa Rica Citi A tiempo completo

    The Compl Bus Control Manager provides full leadership and supervisory responsibility. Provides operational/service leadership and direction to team(s). Applies in-depth disciplinary knowledge through provision of value-added perspectives or advisory services. May contribute to the development of new techniques, models and plans within area of expertise....


  • Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health....

  • Finance QA

    hace 6 meses


    Heredia, Costa Rica Citi A tiempo completo

    **Responsibilities**: - Contributes to the design, roll-out and governance of financial solutions, including: - Participates in formulating and setting strategic direction for the process, organization and architecture covering Finance across Citi businesses, products, functions and locations - Assists in setting business and information architecture...

  • Internal Auditor

    hace 6 meses


    Heredia, Costa Rica DHL A tiempo completo

    **About DHL and Internal Audit**: DHL Group the logistics provider of the world with over 580,000 employees in more than 220 countries and territories. We are an organization that is not just moving goods around, we have a very clear purpose, and we are: Connecting People. Improving Lives. We provide challenges and opportunities for personal and professional...


  • Heredia, Costa Rica Stryker A tiempo completo

    **Why join Stryker?**: Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific. **Know someone at Stryker?**: **Who we Want**: - ** Assertive...

  • Internal Auditor

    hace 7 meses


    Heredia, Costa Rica DHL A tiempo completo

    **About DHL and Internal Audit**: DHL Group the logistics provider of the world with over 580,000 employees in more than 220 countries and territories. We are an organization that is not just moving goods around, we have a very clear purpose, and we are: Connecting People. Improving Lives. We provide challenges and opportunities for personal and professional...


  • Heredia, Costa Rica 360training A tiempo completo

    360training is seeking a **Compliance Reporting Specialist** to join our growing team. The **Compliance Reporting Specialist** will be responsible for submitting students’ course completion credit hours to the regulators for fulfilling the compliance requirement, by strictly following the reporting schedule and SOP’s respectively for each Industry and...

  • Manager-payroll

    hace 6 meses


    Heredia, Costa Rica Moody's A tiempo completo

    At Moody's, we unite the brightest minds to turn today’s risks into tomorrow’s opportunities. We do this by striving to create an inclusive environment where everyone feels welcome to be who they are—with the freedom to exchange ideas, think innovatively, and listen to each other and customers in meaningful ways. **Job Overview**: The Payroll Manager...


  • Heredia, Costa Rica Equifax A tiempo completo

    A Training Specialist is effectively responsible for learning & becoming proficient in assigned processes. This person will not only deliver training as needed but also will be in charge of assessing knowledge among the trainees and communicating results on a regular basis to all the parties involved. A trainer will be responsible for overseeing all...

  • Project Manager

    hace 7 meses


    Heredia, Costa Rica Critical Mass A tiempo completo

    The Project Manager reports to a Program Manager. Works closely with Directors and Subject Matter Experts, designers, developers and quality to ensure flawless project execution, efficient resource allocation, project financial sanity and client satisfaction. He/She supports grows project delivery discipline and helps to develop processes, documentation,...

  • Treasury Manager

    hace 6 meses


    Heredia, Costa Rica Workday A tiempo completo

    Your work days are brighter here. At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that really set us apart was our culture. A culture which was driven by our value of putting our...

  • Manager-Payroll

    hace 7 meses


    Heredia, Costa Rica Moody's A tiempo completo

    At Moody's, we unite the brightest minds to turn today’s risks into tomorrow’s opportunities. We do this by striving to create an inclusive environment where everyone feels welcome to be who they are—with the freedom to exchange ideas, think innovatively, and listen to each other and customers in meaningful ways.  If you are excited about this...

  • Kyc Operations Manager

    hace 6 meses


    Heredia, Costa Rica Citi A tiempo completo

    **The KYC Operations Manager is an intermediate management-level position responsible for providing full leadership and direction to a team of employees to provide Anti-Money Laundering (AML) monitoring, governance, oversight and regulatory reporting services in coordination with the Compliance and Control team. The overall objective of this role is to...

  • Kyc Operations Manager

    hace 6 meses


    Heredia, Costa Rica Citi A tiempo completo

    The KYC Operations Manager is an intermediate management-level position responsible for providing full leadership and direction to a team of employees to provide Anti-Money Laundering (AML) monitoring, governance, oversight and regulatory reporting services in coordination with the Compliance and Control team. The overall objective of this role is to ensure...