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Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life.
Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.
Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.A Day in the LifeAs a Quality Systems Specialist, you will serve as an independent quality representative supporting regulated IT projects across the organization.
You will review validation and lifecycle documentation, provide guidance to project teams, assess compliance risks, and help ensure technology solutions are implemented in accordance with quality and regulatory requirements.
This role offers exposure to a broad portfolio of technologies, including cloud solutions, data platforms, automation, and emerging digital initiatives.
This position is based in Bogotá, Colombia and follows a flexwork model.ResponsibilitiesReview and assess validation deliverables, testing documentation, risk assessments, and system lifecycle records for regulated IT solutionsProvide quality and validation guidance to project teams throughout planning, execution, and implementation activitiesEvaluate project documentation to ensure alignment with quality processes, regulatory requirements, and internal standardsPartner with global stakeholders to support the implementation of compliant IT systems and processes.Assess requirements, testing evidence,



and risk management activities to verify readiness for system deploymentSupport audit readiness activities, corrective and preventive action (CAPA) investigations, supplier quality initiatives, and regulatory assessments as neededContribute to continuous improvement initiatives that strengthen quality, compliance, and validation practicesCollaborate with cross-functional teams across multiple regions within a global virtual environmentRequired QualificationsBachelor's degree and 2+ years of experience in quality, compliance, validation, or regulated environments such as medical devices, pharmaceuticals, life sciences, manufacturing, or related regulated industriesExperience reviewing, executing, or approving validation deliverables for regulated systemsExperience supporting validation activities throughout the regulated IT system lifecycleKnowledge of validation lifecycle methodologies and risk-based validation principlesAdvanced English proficiency with the ability to collaborate effectively with general stakeholdersPreferred QualificationsExperience within the medical device, pharmaceutical, or broader life sciences industryKnowledge of ISO *****, FDA 21 CFR Part 11,



and European Union Annex 11 regulationsExperience supporting global project teams in a virtual, cross-functional environmentExperience with audit support, CAPA processes, supplier quality activities, or regulatory reviewsProject management experience and ability to present recommendations to stakeholders and leadershipPhysical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageThis position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP)Benefits and resources, and competitive compensation plans designed to support you at every career and life stageIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.
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📌 Quality Systems Specialist-1. (Bogotá)
🏢 Medtronic
📍 Bogotá