CAPA Manager

Medtronic plc; Puerto Bogotá; On-site; COP 60,000,000 - 110,000,000; Full time

Benefits offered by this job

Competitive benefits

Medtronic Incentive Plan

Job summary

Medtronic plc in Colombia seeks a QA professional to lead CAPA execution and sustain compliant quality systems. You will monitor data trends, coordinate cross-functional audits, and ensure documentation aligns with ISO 13485 and Medical Device Regulation. Fluency in English is required as you interact with global teams.

The role is on-site in Colombia, offering a competitive benefits package and an incentive plan aligned with Medtronic standards.

Qualifications

• Bachelor's degree in a relevant field.
• Minimum 5 years of experience in QA, CAPA, or quality
• Knowledge of ISO 13485 and Medical Device Regulation
• Fluent English communication skills

Responsibilities

• Leads CAPA execution and ensures timely completion.
• Monitors quality data trends and escalates issues.
• Collaborates with cross-functional teams for audits and inspection readiness.
• Ensures CAPA documentation meets quality system requirements.
• Provides guidance on regulatory and internal policies to ensure compliance.

Skills

CAPA leadership

Quality systems

Regulatory knowledge

Audit coordination

Process analysis

Fluent English

Education

Bachelor's degree

Job description

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 LifeResponsibilities may include the following and other duties may be assigned :Provides leadership and oversight for CAPA execution through assigned quality or CAPA support resources, ensuring adequate planning, resourcing, follow-through, and timely completion of corrective and preventive actionsMonitors CAPA, nonconformance, and quality data trends to identify systemic issues, support escalation decisions, and drive continuous improvement within the quality management systemReviews and communicates CAPA-related trends, investigation outcomes, and associated quality signals to relevant stakeholders and cross-functional forums to support alignment, risk evaluation, and consistent execution of quality actionsEnsures CAPA-related documentation, investigations, and associated corrective actions meet applicable quality system requirements and are maintained in accordance with established proceduresSupports escalation and initiation of CAPA or CAPA requests when quality issues, nonconformances, or field-related concerns meet established criteriaProvides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure complianceWorks directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulationsCollaborates and leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the auditsRequired Knowledge and Experience:Bachelor's degreeMinimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experienceQuality Systems and ISO 13485 & Medical Device Regulation knowledgeFluent English levelPhysical Job RequirementsThe 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 [e-mail] .Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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).