Quality Engineer II

Penumbra; Norte; Presencial; COP 48.000.000 - 80.000.000; Jornada completa

Descripción de la vacante

Penumbra is seeking a Quality Engineer II to support QMS activities for medical devices, analyze quality data, investigate nonconformances, and drive CAPA to improve products and processes. You will collaborate with cross-functional teams to ensure regulatory compliance and delivery of high-quality solutions.

The role requires a bachelor’s degree in engineering, 3+ years in quality engineering, manufacturing and medical device experience, and strong communication in English.

Formación

• Bachelor's degree in engineering or related field.
• 3+ years of experience in quality engineering.
• Fluent English.
• Familiar with QSR, ISO regulations and quality standards.

Conocimientos

Quality engineering

English proficiency

Communication skills

Educación

Bachelor's degree in engineering

Herramientas

MS Word

MS Excel

MS PowerPoint

Descripción del empleo

Summary

The Quality Engineer II supports Quality Management System (QMS) activities for new and existing products, manufacturing processes, and quality controls to ensure compliance with regulatory requirements and quality standards. This role analyzes quality data, investigates nonconformances, identifies root causes, and drives corrective and preventive actions to improve product and process performance. Working closely with cross-functional teams, the Quality Engineer II contributes to continuous improvement initiatives, supports product and process validations, and helps ensure the delivery of safe, effective, and high-quality medical devices.

Qualifications

Requires a bachelor’s degree in engineering or a related field,

3+ years of experience in quality engineering.

Proficiency in English.

Requires familiarity with QSR, ISO, and other applicable regulations and laws.

Manufacturing experience.

Medical device industry experience.

Demonstrates excellent verbal, written, and interpersonal communication skills.

Proficiency in MS Word, Excel, and PowerPoint.

₡0 - ₡0 a month