Quality Assurance Manager

About the Company

ARTIDIS AG is a clinical-stage health-tech start-up that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. Their nanotechnology platform integrates clinical data into the ARTIDISNET digital platform to enable personalized cancer treatment plans.

Responsibilities

• Create, review, and train quality-related processes and procedures
• Maintain oversight of the quality management system (QMS), including records, changes, CAPA, and validations
• Document internal audits and quality assurance activities
• Support Gauge Management, Risk Management, and Training Management
• Ensure QMS compliance for inspections and audits
• Provide support during regulatory inspections and perform auditing efforts
• Identify quality system improvements and investigate improved quality practices

Requirements

• At least 3 years of experience in an EN ISO 13485 quality-controlled environment
• Strong knowledge of EN ISO 13485, FDA QMSR, MDSAP, and EU IVDR
• Hands-on experience in incoming inspection and release of goods
• Experience using AI for QMS purposes
• Proficiency with quality systems and document control platforms
• Excellent written and spoken English
• Strong analytical skills and ability to interpret quality data
• Ability to work in a dynamic, fast-paced start-up environment