Quality System Specialist.

COS Medtronic Shared Services Americas S.A.S.; Bogotá ciudad; Presencial; COP 45.000.000 - 65.000.000; Jornada completa

Descripción de la vacante

Medtronic is hiring for a Vigilance/QA regulatory role in Colombia. The candidate will handle complaint processing, regulatory reporting, and CAPA activities with a focus on GDP, ISO 13485, and post‑market surveillance standards.

The role requires a bachelor’s degree in a related field and 2–3 years in a QA/RA or Vigilance function, with fluent English and strong MS Office skills. Prior medical device experience is advantageous.

Formación

• Bachelor's degree in a related field required.
• Fluent English level required.
• 2–3 years in Post Market Surveillance, Vigilance or QA/RA.
• MS Office Suite proficiency.
• 3+ years in medical device quality environment is a plus.
• Understanding of GDP and ISO 13485.

Responsabilidades

• Execute complaint handling activities and regulatory reporting tasks using the Global Complaint Handling system.
• Assist in training new personnel on system activities, including CAPA management.
• Monitor regulatory reporting deadlines and ensure timely submission to authorities.
• Review accuracy and completeness of regulatory reports before submission.
• Participate in CAPA investigations to identify root causes of quality issues.
• Audit processes and ensure adherence to QMS; identify deviations and implement corrective actions.
• Support quality documentation, process mapping, and change initiatives.
• Prepare reports and analyze data to identify trends for process improvement.

Conocimientos

Fluent English

MS Office Suite

Regulatory reporting

CAPA management

Complaint handling

Educación

Bachelor's Degree in Medical/ Biological/ Pharmaceutical/ Engineering

Herramientas

Global Complaint Handling system

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.

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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.