Quality Assurance Specialist at Kardium

Make an impact at Kardium as a Quality Assurance Specialist in Engineering (Hybrid) within Burnaby, BC. Work alongside engineering experts to uphold the highest quality standards in medical devices.

As a key member of Kardium’s QA team, you’ll help ensure top quality in our revolutionary Globe® Pulsed Field System. Ideal candidates possess over 3 years of relevant experience, a strong grasp of ISO 13485, and effective communication skills. This hybrid role emphasizes teamwork, documentation accuracy, and continuous improvement in our Quality Management System, all within a supportive environment.

Key Responsibilities:

• Conduct critical reviews of validation documentation

• Execute QA releases on incoming and finished goods

• Coordinate change control activities effectively

• Participate in internal audits for continuous improvement

• Support root cause analysis and documentation control

Requirements:

• Bachelor’s degree in engineering or technical field

• 3+ years of QA experience in biotech/medical devices

• In-depth knowledge of FDA QSR and EU MDD

• Familiar with electronic document control systems

• Highly organized with great communication skills

Enhance patient outcomes through exceptional quality assurance practices at Kardium.
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