Basel Metropolitan Area
Quality Leader in the medical technology industry. Deep knowledge in handling NC, CAPA, OBS to improve product and production safety. Experience with regulations including but not limited to: FDA, EU MDR, ISO 13485:2016, and ISO 17025. My expertise in MDR/FDA product analysis codes helps optimize products and consider customer feedback. By attending training and conferences, I stay up-to-date on current industry trends and leverage my network for potential collaborations. Thanks to my leadership experience, I can derive company and departmental goals and take the necessary steps to achieve them. Through my interconnected thinking, precise, and structured work approach, I am able to set optimal priorities and find the best solutions. In addition: - Experience in implementing projects and processes - 8+ years of managing teams and working groups (15+ people, 1 levels of reporting), incl. cross- functional and global teams - Certificate Lean Green Belt - Ready to travel
- Consolidation and harmonization of global processes - Creating and defining new key performance indicators (KPIs) - Contact person for audit questions in the area of quality / technology - Contributing expert opinion to NC, CAPA and field actions - Implementation and assessment of PMS requests - Consolidation and harmonization of global processes - Creation and definition of new key performance indicators (KPI) - Contact person for audit questions in the area of quality / technology - Contribution of expert opinion to NC, CAPA and field actions - Implementation and assessment of PMS requests
- Management responsibility for 15 employees - Development and implementation of training for software applications (worldwide) - Preparation of budget and investment planning - Development of department-specific KPIs - Device Calibration Lead EMEA - Torque Test Bench
Production of prototypes and custom-made products (CMP) Creating and documentation of GMP documents Application of GD&T