Quality Systems Specialist

Quality Systems SpecialistCareers that change lives start here. 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.The Quality Systems Specialist role in LATAM is responsible for supporting the implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes, ensuring compliance with regulatory requirements, internal quality standards, and corporate policies. This position supports quality documentation, audits, training activities, corrective and preventive actions (CAPA), and process improvement initiatives across the region. This is a remote work model position based in Bogotá, Colombia.Responsibilities may include the following and other duties may be assigned:Review and process Change Requests within Medtronic's Product Lifecycle Management (PLM/MAP) system, ensuring compliance with Quality Management System (QMS) requirements, system standards, and Good Documentation PracticesPartner with stakeholders across the Americas and EurAsia regions to provide guidance, resolve quality system inquiries, and maintain effective collaboration throughout QMS activitiesMonitor and support quality system processes, ensuring compliance with internal policies, regulatory requirements, and established quality standardsAnalyze quality-related data, identify trends, and contribute to continuous improvement initiatives through process enhancements, projects, and CAPA activitiesSupport audits and inspections by preparing documentation, addressing findings, and coordinating with auditors, inspectors, and internal process ownersPrepare reports and communicate quality system updates, recommendations, and key metrics to relevant stakeholdersDeliver training and ongoing support on quality system processes while promoting best practices and consistency across global teamsCollaborate with process owners and cross-functional teams to identify opportunities for improving quality system effectiveness and achieving organizational objectivesRequired Knowledge and Experience:Bachelor's degree in Engineering, Life Sciences, or a related scientific field1-2 years of experience in Quality Systems, with working knowledge of Quality Management System (QMS) processesExperience with Document Control and Good Documentation Practices (GDP)Strong verbal and written communication skills in both English and SpanishProficiency in Microsoft Office applications, particularly Excel, and experience working with quality-related systems and toolsStrong stakeholder management, communication, and interpersonal skillsAbility to work effectively in cross-functional teams and independentlyDemonstrated ability to work autonomously once fully trained and familiar with established processes, taking ownership and accountability for day-to-day Quality Systems activitiesStrong organizational, prioritization, and problem-solving skills with a high level of attention to detail and accuracyResults-oriented, proactive, and adaptable, with a strong commitment to quality, compliance, and continuous improvementPreferred qualifications include knowledge of ISO 9001:2015 and/or ISO 13485:2016 standards, exposure to continuous improvement methodologies such as Lean, Six Sigma, or Kaizen, experience supporting training activities, and previous mentoring or coaching experiencePhysical Job Requirements The 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.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io & CompensationMedtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).