Quality Engineer II
- Penumbra
- Cartago, Colombia
- CRC 18,000,000 – CRC 26,000,000
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.
Skills
- Quality Management Systems (QMS)
- Root Cause Analysis
- Corrective and Preventive Action (CAPA)
- ISO 13485
- FDA QSR (21 CFR 820)
- Process Validation
- Statistical Process Control (SPC)
