QA Manager - Medical Devices & QMS Champion

Artidis; Basel; Presencial; CHF 120 000 - 160 000; Tempo integral

Resumo da oferta

Artidis, a pioneering clinical stage health technology company, seeks a Quality Assurance Manager in Basel to document and review EN ISO 13485 quality processes and ensure product compliance before market launch. You will report to the Head of Quality Management and coordinate audits, risk management, and training.

The role requires hands-on QC experience, strong analytical skills, and excellent English, within a fast-paced startup environment that values initiative and cross-functional

Qualificações

• Experience with EN ISO 13485 quality-managed environment.
• Hands-on experience in incoming inspection and release of goods.
• Strong analytical skills to interpret quality data and identify trends.
• Excellent written and spoken English.
• Ability to work in a dynamic startup or scale-up environment.

Responsabilidades

• Creates, reviews and trains quality related processes and procedures.
• Collaborates with other departments to support quality processes.
• Identifies training requirements and maintains QMS records.
• Oversees internal audits, corrective actions and preventive actions.
• Supports risk management, gauge management and training management.
• Ensures QMS documentation is accurate and compliant for inspections.

Conhecimentos

AI for QMS

QMS maintenance

ISO 13485 knowledge

3+ years EN ISO 13485

Incoming inspection

Quality data analysis

Startup adaptability

English proficiency

Cross-functional communication

Documentation control

Ferramentas

ERP/MRP systems

Descrição da oferta de emprego

Artidis, a pioneering clinical stage health technology company, seeks a Quality Assurance Manager in Basel to document and review EN ISO 13485 quality processes and ensure product compliance before market launch. You will report to the Head of Quality Management and coordinate audits, risk management, and training.

The role requires hands-on QC experience, strong analytical skills, and excellent English, within a fast-paced startup environment that values initiative and cross-functional