Principle Quality Systems Specialist

hace 3 semanas


Bogotá, Bogotá D.E., 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 healthcare worldwide.

Come strengthen your specialized skills and enhance your expertise.

We'll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that's best for you.

Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.

A Day in the Life

  • Serves as the quality expert for assigned programs and is responsible for making strategic quality decisions throughout the product lifecycle. Provides a proactive frontend approach to product quality. Ensures deliverables are aligned to process.
  • Delivers strong written and verbal communication skills with ability to communicate effectively to a wide audience, including subordinates, peers, and superiors, and requires mínimal supervision.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Provides oversight for the development and maintenance of quality programs, systems, and processes that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Lead and influence Quality System procedures and process improvements including developing and updating and owning procedures.
  • In collaboration with operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes.
  • Trains and mentors other Quality department staff to perform quality duties.

Must Haves

  • 7+ years of experience with a bachelor's degree or 5+ years of experience with an advanced degree
  • Nonproduct software including 21 CFR Part 11 and/or healthcare validation delivery experience
  • Proficiency in Microsoft Tools including Word, Excel, Teams, SharePoint
  • Proficiency in multitasking and time management
  • Experience with validation of various system hosting configurations (cloud, onprem)
  • Proficiency with data migration activities

Nice to Haves

  • Previous Medtronic experience
  • Has a history of completing successful projects and driving positive compliance outcomes
  • Solid working knowledge of FDA 21 CFR Part 11, 21 CFR Part 820, QSR/ ISO 13485 regulations and standards
  • History of driving results with a sense of urgency, good communications skills, and ability to manage details.
  • Ability to learn quickly and prioritize tasks in a fast paced and dynamic environment
  • Experience shifting CSV to CSA implementation

Our Commitment

Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.

We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact.

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.


About Medtronic
Bold thinking. Bolder actions. We are Medtronic.


We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.

In everything we do, we are
engineering the extraordinary.

Your Answer
LI-Remote

  • Bogotá, Bogotá D.E., 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 healthcare...


  • Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    **Careers that Change LivesA 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...


  • Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

    Requisition Number: AMER28362Employment Type: Full-timeLocation: BogotaJob 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 of...


  • Bogotá, Bogotá D.E., 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...

  • Data Quality Specialist

    hace 3 semanas


    Bogotá, Bogotá D.E., Colombia Capgemini A tiempo completo

    Descripción breve We are seeking a highly skilled and detail-oriented Data Quality Specialist to join our team. The ideal candidate will have expertise in Identity Management (IDM), Comprehensive Data Quality (CDQ), and proficiency in Python programming language. The primary responsibility of this role is to ensure the accuracy, completeness, and...


  • Bogotá, Bogotá D.E., 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...


  • Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

    Requisition Number: AMER28043Employment Type: Full-timeLocation: BogotaJob Summary: This specialist will support the configuration of the Manufacturing Execution System (MES) and other associated process control systems for new product introductions and existing production activities. The position is aligned with key business areas to achieve high levels of...


  • Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    Careers that Change LivesWe 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...


  • Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    Careers that Change LivesSupport Latin America Region Post Market Vigilance activities related to Field Corrective Action (FCA).A Day in the LifeResponsibilities 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 specifications and...

  • IT Systems Specialist

    hace 3 semanas


    Bogotá, Bogotá D.E., Colombia DAI A tiempo completo

    Conflict Stability and Security Fund, CIEP - Strategic Institutional Support to Tackle Illicit Financial Flows in Latin America ProgrammeRole:IT SYSTEMS SPECIALISTStart date: MAY THE 12THEnd date: MARCH THE 31ST 2024Project DescriptionThe Conflict Stability and Security Fund (CSSF) Combatting Illicit Economies Programme (CIEP) is a regional programme focused...

  • Prin Quality Systems Spec

    hace 3 semanas


    Bogotá, Bogotá D.E., 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...

  • Sr Quality Systems Spec

    hace 3 semanas


    Bogotá, Bogotá D.E., 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 the Global...

  • IT Quality Systems Spec

    hace 3 semanas


    Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    **Careers that Change LivesThis 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 Spec

    hace 3 semanas


    Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    Careers that Change LivesA Day in the LifeResponsibilities 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 external...


  • Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    Careers that Change LivesA Day in the LifeResponsibilities 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 external...


  • Bogotá, Bogotá D.E., Colombia PayU A tiempo completo

    About PayUPayU, a leading payment and Fintech company in 50+ high-growth markets throughout Asia, Central and Eastern Europe, Latin America, the Middle East and Africa, part of Prosus group, one of the largest technology investors in the world is redefining the way people buy and sell online for our merchants and millions of consumers.As a leading online...


  • Bogotá, Bogotá D.E., 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 requirements are...

  • Quality Control

    hace 3 semanas


    Bogotá, Bogotá D.E., Colombia Home Sweet Home Productions A tiempo completo

    Home Sweet Home Productions is a dynamic team dedicated to serving the Real Estate industry by delivering innovative and captivating content to Realtors. We pride ourselves on our commitment to excellence and creativity in every project we undertake. Currently, we are seeking a highly skilled individual to join us in the role of Quality Control Specialist on...


  • Bogotá, Bogotá D.E., Colombia ConvaTec A tiempo completo

    About the Role:The CSV Analyst will play an essential role in ensuring that IT managed GxP computerized systems and infrastructure are validated or qualified according to corporate quality standards.Duties and Responsibilities:Evaluate proposed new computerized systems or software to assess GxP impact and provide guidance on the risk-based validation...


  • Bogotá, Bogotá D.E., Colombia Cisco Systems A tiempo completo

    What You'll DoThe 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)...