Quality Systems Specialist

Quality Systems Specialist

Careers 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 Practices
• Partner with stakeholders across the Americas and Eur Asia regions to provide guidance, resolve quality system inquiries, and maintain effective collaboration throughout QMS activities
• Monitor and support quality system processes, ensuring compliance with internal policies, regulatory requirements, and established quality standards
• Analyze quality-related data, identify trends, and contribute to continuous improvement initiatives through process enhancements, projects, and CAPA activities
• Support audits and inspections by preparing documentation, addressing findings, and coordinating with auditors, inspectors, and internal process owners
• Prepare reports and communicate quality system updates, recommendations, and key metrics to relevant stakeholders
• Deliver training and ongoing support on quality system processes while promoting best practices and consistency across global teams
• Collaborate with process owners and cross-functional teams to identify opportunities for improving quality system effectiveness and achieving organizational objectives

Required Knowledge and

Experience:

• Bachelor's degree in Engineering, Life Sciences, or a related scientific field
• 1-2 years of experience in Quality Systems, with working knowledge of Quality Management System (QMS) processes
• Experience with Document Control and Good Documentation Practices (GDP)
• Strong verbal and written communication skills in both English and Spanish
• Proficiency in Microsoft Office applications, particularly Excel, and experience working with quality-related systems and tools
• Strong stakeholder management, communication, and interpersonal skills
• Ability to work effectively in cross-functional teams and independently
• Demonstrated ability to work autonomously once fully trained and familiar with established processes, taking ownership and accountability for day-to-day Quality Systems activities
• Strong organizational, prioritization, and problem-solving skills with a high level of attention to detail and accuracy
• Results-oriented, proactive, and adaptable, with a strong commitment to quality, compliance, and continuous improvement
• Preferred 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 experience

Physical

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.

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