CAPA Manager

Medtronic plc; Bogotá; In loco; COP 90.000.000 - 150.000.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Flexible benefits package

Medtronic Incentive Plan (MIP)

Descrizione del lavoro

Medtronic plc in Bogotá seeks a CAPA leader to drive corrective and preventive actions within the quality management framework. You will oversee CAPA execution, monitor data trends, and coordinate cross‑functional responses to ensure compliance with quality system requirements.

The role requires a strong knowledge of ISO 13485 and medical device regulation, a Bachelor’s or higher degree, and fluent English.

Competenze

• Bachelor's degree in a relevant field with 5+ years of experience, or an advanced degree with 3+ years of experience.
• Knowledge of Quality Systems and ISO 13485 and Medical Device Regulation.
• Fluent English.

Mansioni

• Provides leadership and oversight for CAPA execution through assigned quality or CAPA support resources, ensuring timely completion of corrective actions.
• Monitors CAPA, nonconformance, and quality data trends to identify systemic issues and drive continuous improvement.
• Reviews CAPA-related trends, investigation outcomes, and quality signals to support risk evaluation and cross-functional alignment.
• Ensures CAPA documentation and investigations meet quality system requirements and established procedures.
• Supports escalation and initiation of CAPA requests when quality issues meet criteria.
• Interprets policies, regulations, and internal rules to ensure compliance.
• Works with operating entities to provide process analyses oversight to enforce requirements and meet regulations.
• Collaborates with audit teams and inspectors to prepare for audits and address findings.

Conoscenze

Quality systems knowledge

ISO 13485

English fluency

Formazione

Bachelor's degree

Advanced degree

Descrizione del lavoro

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

• 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 actions
• Monitors CAPA, nonconformance, and quality data trends to identify systemic issues, support escalation decisions, and drive continuous improvement within the quality management system
• Reviews 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 actions
• Ensures CAPA-related documentation, investigations, and associated corrective actions meet applicable quality system requirements and are maintained in accordance with established procedures
• Supports escalation and initiation of CAPA or CAPA requests when quality issues, nonconformances, or field‑related concerns meet established criteria
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
• Collaborates and leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits

Required Knowledge and Experience

• Bachelor's degree Minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience
• Quality Systems and ISO 13485 & Medical Device Regulation knowledge
• Fluent English level

Physical Job Requirements

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).

Medtronic leads 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

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. For further information about the E-Verify program, please click here.

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