This international Medical Device company is located nearby Breda.
They are active in multiple products and have their distribution side for the European Union also on this location.
You will support and coordinate on location EDC processes in the QA team. Advises and provides direction to sustain and improve the Quality System standards for the department and will do your internal audits. Next to that you create the program for documentation control and employee training programs to help ensure regulatory compliance. You also will Interacts with sources of supply regarding product quality complaints.
- Maintain appropriate operating procedures and policies within corporate guidelines
- Perform, coordinate and follow up on internal audits
- Perform Country Specific audits and product inspections
- Facilitate and coordinate any CAPAs required for the RO facility
- Participate as needed in regulatory audits to ensure compliance with FDA and ISO regulations
- Participate in training and development opportunities to enhance operational excellence, flexibility and personal development as determined by the DC Manager /Supervisor
- Perform other job related duties as determined and assigned by management
- 3+ years experience in Medical Devices
- Minimum of a MBO by education
- Knowledge of SAP/ERP system
- Understanding of applicable ISO 13485 requirements and knowledge of Lean & Six Sigma preferred
- Proficient computer skills, incl. MS office suite