Quality Engineer II

Penumbrainc; Norte; Presencial; COP 60.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

Penumbrainc is seeking a Quality Engineer II to support QMS activities for new and existing products, processes, and quality controls to ensure regulatory compliance and high-quality medical devices.

The role analyzes quality data, investigates nonconformances, identifies root causes, and drives CAPAs while collaborating with cross-functional teams to support validations and continuous improvement initiatives.

Formación

• Bachelor’s degree in engineering or related field.
• 3+ years of experience in quality engineering.
• Proficiency in English.
• Familiarity with QSR, ISO and applicable regulations.
• Manufacturing experience.
• Medical device industry experience.
• Strong verbal and written communication skills.

Responsabilidades

• Support Quality Management System activities for new and existing products, processes and quality controls.
• Analyze quality data, investigate nonconformances, and identify root causes.
• Drive corrective and preventive actions to improve product and process performance.
• Collaborate with cross-functional teams to support validations and continuous improvement initiatives.

Conocimientos

Communication skills

English proficiency

Interpersonal skills

Educación

Bachelor's degree in Engineering

Herramientas

MS Word

Excel

PowerPoint

Descripción del empleo

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.

• 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.