Quality Systems Specialist-1.

Medtronic plc; Bogotá; Hybrid; COP 80.000.000 - 120.000.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Flexible benefits package

Short-term incentive plan (MIP)

Zusammenfassung

Medtronic plc in Bogotá, Colombia seeks a Quality Systems Specialist to support regulated IT projects. You will review validation and lifecycle documentation, provide guidance to teams, assess compliance risks, and help ensure technology solutions meet quality and regulatory requirements.

You will work with cloud solutions, data platforms, automation, and digital initiatives within a global virtual environment, partnering with cross-functional stakeholders across regions.

Qualifikationen

• Bachelor's degree in a quality, regulatory, or life sciences field.
• Experience reviewing or approving validation deliverables for regulated systems.
• Advanced English proficiency and collaboration with global stakeholders.

Aufgaben

• Review validation deliverables, testing documentation, risk assessments, and lifecycle records for regulated IT solutions.
• Provide quality and validation guidance to project teams during planning, execution, and implementation.
• Evaluate project documentation for alignment with quality processes, regulatory requirements, and internal standards.
• Partner with global stakeholders to support compliant IT systems and processes.
• Assist with audit readiness activities, CAPA investigations, supplier quality initiatives, and regulatory reviews.
• Contribute to continuous improvement of quality, compliance, and validation practices.

Kenntnisse

Quality systems

Regulatory compliance

Validation

Regulated environments

English communication

Ausbildung

Bachelor's degree

Jobbeschreibung

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.

A Day in the Life

As 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.

Responsibilities

• Review and assess validation deliverables, testing documentation, risk assessments, and system lifecycle records for regulated IT solutions
• Provide quality and validation guidance to project teams throughout planning, execution, and implementation activities
• Evaluate project documentation to ensure alignment with quality processes, regulatory requirements, and internal standards
• Partner 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 deployment
• Support audit readiness activities, corrective and preventive action (CAPA) investigations, supplier quality initiatives, and regulatory assessments as needed
• Contribute to continuous improvement initiatives that strengthen quality, compliance, and validation practices
• Collaborate with cross-functional teams across multiple regions within a global virtual environment

Required Qualifications

• Bachelor'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 industries
• Experience reviewing, executing, or approving validation deliverables for regulated systems
• Experience supporting validation activities throughout the regulated IT system lifecycle
• Knowledge of validation lifecycle methodologies and risk-based validation principles
• Advanced English proficiency with the ability to collaborate effectively with global stakeholders

Preferred Qualifications

• Experience within the medical device, pharmaceutical, or broader life sciences industry
• Knowledge of ISO 13485, FDA 21 CFR Part 11, and European Union Annex 11 regulations
• Experience supporting global project teams in a virtual, cross-functional environment
• Experience with audit support, CAPA processes, supplier quality activities, or regulatory reviews
• Project management experience and ability to present recommendations to stakeholders and leadership

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.

Benefits & Compensation

• Medtronic offers a competitive Salary and flexible Benefits Package
• This 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 stage

It 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.