Quality Systems Specialist

hace 3 semanas


Bogota, Colombia Medtronic A tiempo completo

**Careers that Change Lives
**A Day in the Life**:

- Execution of Complaint Handling activities: Regulatory decisions and regulatory reporting (drafting and submission).
- Execute tasks using Complaint Handling tools/systems (Global Complaint Handling system).
- Ensure closure of regulatory reports with investigation are done timely, consistently and in compliance with regulatory requirements.
- Respond to stakeholder inquiries regarding status of regulatory decisions and reports.
- Assist in training new personnel on system activities, including complaint handling, regulatory reporting, and CAPA management.
- Monitor regulatory reporting deadlines and ensure all reports are submitted on time to relevant authorities.
- Review and verify the accuracy and completeness of regulatory reports before submission.
- Participate in CAPA investigations to identify root causes of quality issues and deviations.
- Perform activities within the system to document CAPA activities from stakeholders and global operations units
- Monitor adherence to documented processes and procedures outlined in the QMS. Regularly audit processes to identify any deviations or non-compliance issues and take corrective actions as necessary.
- Participate in projects, process improvement initiatives & respond to stakeholder’s additional requests.
- Review complaint information and assess if the complaint is reportable to the appropriate regulatory bodies.
- Participation in tech/automation initiatives of the organization to improve the overall process of Vigilance.
- Consistently learns and adapts to different regulatory requirements and changes of different regions.
- Support establishment of quality specifications and standards and support the development of processes and standards.
- Facilitate update of quality documentation, process mapping, reviewing processes and assisting with change initiatives.
- Prepare reports, analyze data to identify trends and opportunities for improvement related to the process.
- Escalate high risk incidents to management and PMV team.
- Respond to both Internal and External Audit enquiries in a timely manner and ensure follow-up on action Items to address any audit recommendations.
- Observe all health and safety policies and procedures and take all reasonable care that actions or omissions do not impact on the health and safety of others.
- Work within and actively promote Medtronic’s Mission, corporate strategies, policies, procedures and Code of Conduct.
- Other duties as assigned by the supervisor/manager.

**Must haves**
- Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline
- With minimum of 2 to 3 years of experience in Post Market Surveillance, Vigilance or Quality/Regulatory Affairs or quality systems areas.
- Fluent in English level.
- Computer literacy including sound knowledge of the MS Office Suite or software.
- Good understanding of GDP and its implementation is required.
- Mission Values: Consciously works to bring the Mission alive
- External Focus: Customer responsive, competitive and market driven, leads and supports Change
- Clear Thinking: Translates complexity into simplicity, articulates crisply and clearly
- Driven to Win: Passionate and driven, makes tough decisions in difficult situations
- Inspires Others: Authentic and sets a vision to inspire performance and engage others
- Executes: Takes accountability for and consistently delivers consistent decisions, actions, and results
- Boundaryless: Breaks down silos, collaborates across organizational boundaries
- Global: Culturally agile, strives to understand diverse market needs and responds with creative and effective solutions
- Integrity and Compliance: Practice the highest ethical standards and integrity in every aspect of my job.
- Team player.
- Great communication skills.

**Nice to haves**
- Complaint handling and Post Market Vigilance experience is an advantage.
- Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices is a great advantage.
- Experience in writing comprehensive regulatory reports is an advantage.
- Proven experience as supervisor or relevant role is a plus.
- Good understanding of GDP and its implementation is required. Knowledge of ISO 13485 and its implementation will be an added advantage.
- Previous experience with pharma, medical devices or related fields.
- Sound working knowledge of ISO13485 is an advantage.
- Experience in handling/executing Field corrective action is an advantage.

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create



  • Bogota, Colombia Zimmer Biomet A tiempo completo

    -Requisition Number AMER28362 Employment Type Full-time Location Bogota **Job Summary**: - This is an experienced level position in Quality Management Systems (QMS). This position requires an understanding of applicable global regulations. The Corporate QMS Specialist supports policy and procedures responsibilities, including but not limited to assignment...


  • Bogota, Colombia Spreetail A tiempo completo

    Spreetail is seeking a Listing Quality Specialist to join our team. The Listing Quality Specialist plays a critical role in ensuring the accuracy, completeness, and quality of product listings on our e-commerce platform. The specialist will be responsible for reviewing and analyzing product listings, identifying and resolving issues, and ensuring compliance...


  • Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Bring your talents to an industry leader in medical technology and healthcare solutions - we’re a market...


  • Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives **A Day in the Life Responsibilities may include the following and other duties may be assigned. - Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...


  • Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** Support Latin America Region Post Market Vigilance activities related to Field Corrective Action (FCA). **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Support implementation and compliance to the company’s Quality Management System. - Support establishment of quality...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson MedTech is recruiting for a(n) COMMERCIAL QUALITY SPECIALIST, located in Bogotá Colombia. Responsible for supporting end-to-end quality operations within the North Cluster, ensuring compliance with J&J policies and procedures outlined within the applicable quality management system at Johnson & Johnson. Establishing/maintaining quality...


  • Bogota, Colombia Tetra Tech A tiempo completo

    **Project Summary**: This five-year Third-Party Monitoring and Evaluation (M&E) Project will establish increased access to independent, impartial information on the outputs, progress, quality, challenges, and successes of selected humanitarian assistance projects. This project will provide a comprehensive range of verification, monitoring, and evaluation...


  • Bogota, Colombia Tetra Tech A tiempo completo

    **Project Summary**: This five-year Monitoring and Evaluation Project will establish increased access to independent, impartial information on the outputs, progress, quality, challenges, and successes of selected humanitarian assistance projects. This project will provide a comprehensive range of verification, monitoring, and evaluation services that will...

  • Quality Systems Spec

    hace 4 semanas


    Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal...

  • Prin Quality Systems Spec

    hace 4 semanas


    Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** **We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.** **Bring your talents to an industry leader in medical technology and healthcare solutions - we’re a...

  • Content Specialist

    hace 2 semanas


    Bogota, Colombia Keycafe A tiempo completo

    **Job Title**: Content Specialist **Overview**: We are looking for a Content Specialist to be responsible for creating, editing, and managing content for our organization. The Content Specialist will be responsible for generating high-quality content across a variety of formats, including blogs, website copy, landing pages, and more. The Content Specialist...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. _ - Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for...

  • Data Quality Specialist

    hace 3 semanas


    Bogota, Colombia Capgemini Engineering A tiempo completo

    **Descripción breve**: RESPONSIBILITIES - Uses best practices and tools to analyze and measure data quality and develop action plans to ensure data reliability, completeness, and consistency. - Develop meticulous action plans based on the findings of data quality assessments to enhance data reliability, completeness, and consistency. These action plans may...

  • Data Quality Specialist

    hace 3 semanas


    Bogota, Colombia Capgemini Engineering A tiempo completo

    **Descripción breve**: RESPONSIBILITIES - Uses best practices and tools to analyze and measure data quality and develop action plans to ensure data reliability, completeness, and consistency. - Develop meticulous action plans based on the findings of data quality assessments to enhance data reliability, completeness, and consistency. These action plans may...


  • Bogota, Colombia Nextant LLC A tiempo completo

    We are seeking a highly skilled and motivated Dynamics 365 Business Central Specialist to join our team. As a Dynamics 365 Business Central Specialist, you will be responsible for the successful implementation, customization and support of the Dynamics 365 Business Central platform for our organization. You will work closely with stakeholders to understand...


  • Bogota, Colombia Cisco Systems A tiempo completo

    What You’ll Do The Portfolio Activation Specialist (PAS) role is a highly critical, strategic advisor and Enterprise Agreement onboarding expert that engages with customers to accelerate their consumption of Cisco Enterprise Agreement that transform their business and drive business outcomes. The role resides within the Cisco Customer Experience (CX)...


  • Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Manage and maintain the quality management system documents in a controlled way. - Manage and be an expert in the repository of the quality management system. - Provide support and training in the processes and management of the...

  • Senior Systems Engineer

    hace 4 semanas


    Bogota, Colombia Casa Systems Inc A tiempo completo

    Casa Systems, Inc. (Nasdaq: CASA) is 5G, delivering physical, virtual and cloud-native 5G infrastructure and customer premise networking for high-speed data and multi-service communications networks. Our core and edge convergence technology enables public and private networks for both communications service providers and enterprises. Casa Systems products...

  • Quality Specialist

    hace 3 semanas


    Bogota, Colombia bioMérieux sa A tiempo completo

    **1 Propósito Primario y objetivo General del Puesto**: Asegurar la implementación y la conformidad del Quality Management System a las políticas y procedimientos corporativos, estándares de calidad aplicables y normatividad local y la comunicación y promoción **2 Principales Responsabilidades**: - Asegurar que el proceso de QMS es establecido y...