Quality System Specialist.

Medtronic; Bogotá; Presencial; COP 60.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

Medtronic is seeking a proactive professional for Post-Market Surveillance and Vigilance responsibilities in Bogotá. You will handle regulatory reporting, CAPA investigations, and complaint management while ensuring compliance with global standards and local regulations.

The role requires a Bachelor’s degree in a related field, fluent English, and 2–3 years of relevant experience in QA/RA or post-market activities. MS Office proficiency and knowledge of GDP/ISO 13485 are essential.

Formación

• Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline.
• Fluent English level.
• Minimum of 2 to 3 years of experience in Post Market Surveillance, Vigilance or QA/RA role.
• MS Office Suite.
• At least 3 years of quality experience in the medical device industry or similar environment is an advantage.
• Good understanding of GDP and its implementation.
• Sound awareness and knowledge of ISO 13485 and its implementation.
• Complaint handling and Post Market Vigilance experience is an advantage.
• Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices is a great advantage.
• Experience in writing comprehensive regulatory reports is an advantage.

Responsabilidades

• Execute Complaint Handling activities, regulatory decisions and regulatory reporting.
• Use Global Complaint Handling system and related tools.
• Ensure timely closure of regulatory reports with investigation per regulatory requirements.
• Respond to stakeholder inquiries regarding status of regulatory decisions and reports.
• Assist in training personnel on system activities, complaint handling, regulatory reporting, and CAPA management.
• Monitor regulatory reporting deadlines and submit reports on time to authorities.
• Review and verify accuracy and completeness of regulatory reports before submission.
• Participate in CAPA investigations to identify root causes of quality issues and deviations.
• Document CAPA activities from stakeholders and global operations units.
• Audit processes for deviations or non-compliance and take corrective actions when needed.
• Participate in projects and process improvement initiatives; respond to stakeholder requests.
• Review complaint information and assess if reportable to regulatory bodies.
• Support tech/automation initiatives to improve Vigilance processes.
• Adapt to regulatory changes across regions.
• Support quality documentation updates and change initiatives.
• Prepare reports and analyze data to identify trends and improvement opportunities.
• Escalate high risk incidents to management and PMV team.
• Respond to audit enquiries and address recommendations.
• Observe health and safety policies and ensure actions do not compromise safety.

Conocimientos

Fluent English

Regulatory knowledge

Quality mindset

Attention to detail

Educación

Bachelor's Degree

Herramientas

MS Office

Regulatory systems

Descripción del empleo

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

Responsibilities may include the following and other duties may be assigned:

• 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 regulatory requirements.
• Respond to stakeholder inquiries regarding status of regulatory decisions and reports
• Assist in training new personnel on system activities, including complaint handling, regulatory reporting, and CAPA management
• Monitor regulatory reporting deadlines and ensure all reports are submitted on time to relevant authorities
• Review and verify the accuracy and completeness of regulatory reports before submission
• Participate in CAPA investigations to identify root causes of quality issues and deviations
• Perform activities within the system to document CAPA activities from stakeholders and global operations units
• Monitor adherence to documented processes and procedures outlined in the QMS. Regularly audit processes to identify any deviations or non-compliance issues and take corrective actions as necessary
• Participate in projects, process improvement initiatives & respond to stakeholder’s additional requests
• Review complaint information and assess if the complaint is reportable to the appropriate regulatory bodies
• Participation in tech/automation initiatives of the organization to improve the overall process of Vigilance
• Consistently learns and adapts to different regulatory requirements and changes of different regions
• Support establishment of quality specifications and standards and support the development of processes and standards.
• Facilitate update of quality documentation, process mapping, reviewing processes and assisting with change initiatives
• Prepare reports, analyze data to identify trends and opportunities for improvement related to the process
• Escalate high risk incidents to management and PMV team
• Respond to both Internal and External Audit enquiries in a timely manner and ensure follow-up on action Items to address any audit recommendations
• Observe all health and safety policies and procedures and take all reasonable care that actions or omissions do not impact on the health and safety of others

Required Knowledge and Experience:

• Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline
• Fluent English level
• Minimum of 2 to 3 years of experience in Post Market Surveillance, Vigilance or QA/RA role
• MS Office Suite
• At least 3 years of quality experience in the medical device industry or similar environment is an advantage
• Good understanding of GDP and its implementation is required
• Sound awareness and knowledge of ISO 13485 and its implementation
• Complaint handling and Post Market Vigilance experience is an advantage
• Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices is a great advantage.
• Experience in writing comprehensive regulatory reports is an advantage

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.

Recruitment Fraud Alert

We 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 [e-mail].

Benefits & Compensation

Medtronic 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.

Medtronic offers a competitive Salary and flexible Benefits Package

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).