Quality Assurance Manager

About the role

Artidis, a clinical-stage health technology company focused on tissue analysis and therapy optimization, is hiring a Quality Assurance Manager. The role documents and reviews quality-related processes according to EN ISO 13485, ensuring products meet quality standards before launch. It reports to the Head of Quality Management.

Key responsibilities

• Create, review and train quality-related processes and procedures, and identify training requirements.
• Maintain oversight of the quality management system, including records, changes, corrective and preventive actions, verifications, validations, test method validation and technology transfer.
• Create documentation of internal audits and quality assurance activities, and support Gauge, Risk and Training Management.
• Ensure the QMS is thorough, accurate and compliant so that inspections and audits can be supported.
• Support regulatory inspections and audits, oversee and perform auditing, and identify quality improvements from audit gaps.

Required profile

• Digital native with experience using AI for QMS purposes.
• At least 3 years of experience in an EN ISO 13485 quality-controlled environment.
• Hands-on experience in incoming inspection and release of goods, with quality review and documentation.
• Strong analytical skills, good communication skills, and comfort in a fast-paced start-up or scale-up environment.
• Excellent written and spoken English.

Required skills

• Strong knowledge of EN ISO 13485, FDA QMSR, MDSAP and EU IVDR.
• Proficiency with quality systems and document control platforms; working knowledge of ERP/MRP systems is a plus.

What we offer

• A competitive salary and a bonus for outstanding performance.
• Rapid advancement in an agile start-up with an international team.