Prin Quality Systems Spec

hace 1 mes

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 leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.**

**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, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.**:

- **Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.**:

- **Works directly with process owners to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. This includes managing planning, development, reviews, approvals / releases of quality management system process, work instructions, and form changes to a defined schedule.**:

- **Provides oversight of regulation changes and assess impact to IT governed processes that ensure compliance with established standards and regulations.**:

- **Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.**:

- **Responsible for CAPAs that are part of the IT portfolio and / or CAPAs that are within a business CAPA board oversight that includes IT systemic issues.**:

- **Manages each phase of the systemic issue including issue triage, investigation, action, and effectiveness adhering to the policies, procedures and Key Performance Indicators set within our quality manual.**:

- **Collaborates and influences effectively with global IT leaders and their resources on methods to prevent the issues and staff the work in each of the CAPA phases. Includes project management skills and methods that are used within the IT organization for effective resourcing of work needed to support CAPAs at projects.**:

- **Create and execute change management plans for collaboration of change with the global IT community impacted by the changes to the QMS.**:

- **Support defensibility of processes and changes in external and internal audits. This can entail leading audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.**:

- **Contributes to simplified process approaches and ways to execute to the process changes for the roles in IT that deliver on making it easier to get work done.**:

- **Organizational Impact: Contributes to defining the direction for new processes, standards, or operational plans based on business strategy with a significant impact on work group results.**:

- **Autonomy: Recognized expert, managing large projects or processes.**:

- **Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.**:

- **Coaches, reviews, and delegates work to lower-level specialists.**:

- **May manage large projects or processes that span outside of immediate job area.**:

- **Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation.**

**Must Have: Minimum Requirements**
- **Bachelor’s degree life science.**:

- **7 years of experience with systems validations, maintenances, strategies, and accurate review of specific documentation as required by the IT Product and non-product software validation experience**:

- **CAPA root cause analysis methods skills.**:

- **Audit experience in life science areas.**:

- **Fluent in English level.**:

- **Knowledge in MS Office.**:

- **Collaboration with different regions.**:

- **Use of standard quality management systems tools in the industry (Oracle, Map agile, etc )**:

- **Solid understanding of the quality regulations and auditing techniques required for the medical device industry.**:

- **Ability to create and deliver presentations up to the Executive Committee level.**:

- **Strong influencing and negotiation skills**:

- **High energy and motivation with an ability to quickly adapt to change**:

- **Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance process

  • Prin Quality Systems Spec

    hace 2 semanas

    Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives **We are seeking a driven and talented individual to join our Quality team. This position requires the ability to support the Medtronic IT systems validations, maintenances, strategies, and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing and...

  • Quality Systems Spec

    hace 5 días

    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...

  • Quality Systems Spec

    hace 3 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...

  • IT Quality Systems Spec

    hace 1 semana

    Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives This position requires the ability to support the Medtronic IT systems validations, maintenance, strategies and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing and investigation techniques to ascertain potential areas of risk, qualify their...

  • Sr Quality Systems Spec

    hace 2 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. - Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. - Represent Quality for Service Operations (also referred to as Service & Repair) across...

  • Quality Systems Specialist

    hace 4 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...

  • IT Quality Systems Specialist

    hace 2 semanas

    Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** This position requires the ability to support the Medtronic IT systems validations, maintenance, strategies and accurate review of specific documentation as required by the IT quality processes. The position requires the understanding of auditing and investigation techniques to ascertain potential areas of risk, qualify their...

  • Quality Systems Specialist

    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...

  • Associate Quality Systems Specialist

    hace 3 semanas

    Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable...

  • Principle Quality Systems Specialist

    hace 3 semanas

    Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable...

  • Business Support Spec 2

    hace 3 semanas

    Bogota, Colombia Juniper Networks A tiempo completo

    Business Support Spec 2 As a Business Support Specialist, you will play a pivotal role in ensuring the smooth operation of our business and providing essential support to our teams. You will be responsible for facilitating communication, managing administrative tasks, and optimizing workflows to enhance interaction, efficiency, and...

  • IT Quality Systems Specialist

    hace 4 días

    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...

  • Quality Management Systems Specialist

    hace 2 semanas

    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...

  • Quality Management Systems Specialist

    hace 7 días

    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...

  • Senior Quality Systems Specialist

    hace 2 meses

    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...

  • Senior Quality Systems Specialist

    hace 4 semanas

    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...

  • Accounts Payable Associate, City Storage Systems

    hace 2 semanas

    Bogota, Colombia City Storage Systems A tiempo completo

    **Who we are** At City Storage Systems, we're building Infrastructure for Better Food. We help restaurateurs around the world succeed in online food delivery. Our goal is to make food more affordable, higher quality and convenient for everyone. We're changing the game for restaurateurs, whether they're entrepreneurs opening their first restaurant all the...

  • Computer Systems Validation

    hace 2 semanas

    Bogota, Colombia Convatec A tiempo completo

    **About the Role**: The CSV Analyst will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure, are validated or qualified in accordance with corporate quality standards. **Duties and Responsibilities**: The CSV Analyst will oversee GxP impacting projects to ensure that all applicable regulatory and compliance...

  • Regional Quality Assurance Manager

    hace 4 semanas

    Bogota, Colombia ABBVIE A tiempo completo

    At AbbVie we are lookink for The Regional QA Manager, in this position you will be responsible for providing leadership and oversight of Quality Compliance matters across multiple commercial entities within a region in support of the quality system requirements associated with: pharmaceutical products, combination products and biologics. Specific areas...

  • Quality Management Systems Sr Specialist

    hace 3 semanas

    Bogota, Colombia Zimmer Biomet A tiempo completo

    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...