Quality System Specialist, MedTech- 897292

Our client is a leading company in Switzerland. It is headquartered in Central Switzerland, Burgdorf and has another site in Solothurn. The Company has a global network of production sites, subsidiaries and marketing and sales partners. For our client, we are looking for a Quality System Specialist

Main Responsibilities:

• Maintenance, optimization and expansion of the management system documentation (German and English)
• Ensure quality requirements in the processes and documents
• Support of the process owners in the creation of processes and advice to the entire company on issues relating to the management system
• Support of document control and the training system
• Execution of management system analyzes and reporting (compression / statistical analysis of Q data / creation of trends)
• Support of standards management in cooperation with the relevant departments (standards committee)
• Organization of and participation in customer and authority audits
• Ensuring the implementation and effectiveness of measures from audits
• Assumption of special tasks and participation in projects in the QM area

Qualifications and Experience:

• Technical or scientific basic training or studies
• Experience in quality management or regulatory affairs (ISO 13485, 21 CFR 820, EU 2017/745)
• Further training in quality management is an advantage
• Experienced in advanced handling of software tools (SAP, ViFlow, web interface platforms)
• Very high quality awareness, interdisciplinary interest with a high innovative approach
• Structured, precise and independent way of working
• Excellent communication and coordination skills
• Very good knowledge of English and very good German