Quality Assurance Manager

About the Company

ARTIDIS AG is a clinical-stage health-tech start-up founded in Basel, Switzerland that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, allowing physicians to significantly shorten the current diagnostic process.

Responsibilities

• Create, review, and train quality related processes and procedures
• Collaborate with other departments to support quality related processes
• Maintain oversight of the quality management system including records, changes, CAPA, and validations
• Create documentation of internal audits and quality assurance activities
• Support Gauge Management, Risk Management, and Training Management
• Ensure the QMS is thorough, accurate, and compliant 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
• Proficiency with quality systems and document control platforms
• Experience using AI for QMS purposes
• 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