CAPA & Quality Assurance Lead

Medtronic plc; Bogotá; Presencial; COP 90.000.000 - 150.000.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Flexible benefits package

Medtronic Incentive Plan (MIP)

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality systems knowledge

ISO 13485

English fluency

Educación

Bachelor's degree

Advanced degree

Descripción del empleo

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.