Quality Assurance Manager

ARTIDIS seeks a Quality Assurance Manager in Basel to oversee EN ISO 13485 compliance, manage QMS documentation, and support product launches in a fast-paced health-tech start-up environment.

This position reports to the Head of Quality Management and focuses on maintaining rigorous quality standards for medical products. The role ensures that all processes align with regulatory requirements before products reach the market, while actively driving continuous improvement across the organization.

Responsibilities

• Develop, evaluate, and instruct staff on quality procedures.
• Partner with various teams to facilitate quality workflows.
• Determine necessary training needs for the team.
• Oversee the entire quality management system, including records, corrective actions, process validations, and technology transfers.
• Prepare reports for internal audits and quality assurance initiatives.
• Assist with gauge management and risk management activities.
• Support training management efforts.
• Guarantee the quality management system is comprehensive, precise, and compliant for inspections.
• Provide assistance during regulatory audits and lead internal auditing efforts.
• Spot quality system gaps during reviews and implement improvements.
• Proactively seek out better quality practices and solutions.

Requirements

• Digital native with experience applying AI to quality management systems.
• Practical experience maintaining Quality Management Systems.
• Deep understanding of EN ISO 13485, FDA QMSR, MDSAP, and EU IVDR standards.
• Minimum of three years in an EN ISO 13485 regulated environment.
• Hands-on background in incoming inspections, goods release, and quality documentation.
• Strong analytical abilities to interpret data and spot trends for improvement.
• Ability to thrive in a dynamic, fast-paced start-up or scale-up setting.
• Effective communication skills for cross-functional teamwork and audit preparation.
• Proficiency in quality systems and document control platforms; familiarity with ERP/MRP systems is advantageous.
• Excellent written and spoken English.
• Positive, proactive attitude with strong teamwork and independent work capabilities.
• Reliable, structured, and committed to accurate task completion.

What the company offers

• Competitive salary package.
• Performance-based bonus opportunities.
• Challenging and meaningful tasks.
• Opportunities to take on significant responsibility.
• Work with a strong sense of purpose.

About the company

ARTIDIS is a clinical-stage health-tech start-up based in Basel, Switzerland, known for developing the first nanomechanical biomarker for cancer diagnosis and treatment optimization. The company integrates clinical data into its ARTIDISNET digital platform to streamline diagnostic processes and enable personalized cancer treatment plans. The work environment reflects a typical start-up culture with an intrinsically motivated international team, offering rapid advancement and learning opportunities in a highly agile setting. The company values direct communication and seeks team players who thrive in collaborative environments.

• Clinical-stage health-tech start-up founded in Basel, Switzerland.
• Developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization.
• Integrates clinical data into the ARTIDISNET digital platform to shorten diagnostic processes.
• Enables personalized cancer treatment plans tailored to individual patients' needs.
• Environment is a typical start-up with an intrinsically motivated international team.
• Excellent place for rapid advancement and learning in a very agile environment.
• Looking for a team player who appreciates direct communication.