The company is located nearby Amersfoort. They are one of the biggest market leader in 3D printing for the Medical Device industry. They are ready to expand their QA team. For this position they are looking for multiple QA Medical Device Specialists.
You are responsible for the overall and cross-departmental processes related to Quality. You will join the local QA team and will report to the QARA Manager. This company is active in the Medical Device 3D Printing business located in Utrecht. You will improve the QMS in management and design.
- Designing, maintaining, safeguarding and optimizing the QMS
- Responsible for registering, investigating and reporting internal and external complaints, including trend analyzes
- Responsible for coordinating, conducting and / or supervising internal and external audits
- Ensures continuous improvement, optimization and compliance of the cross-operating business processes department
- Initiates improvement proposals and participates in Lean projects
- Supports the production department and the laboratory in terms of quality
- The preparation and assessment of validation protocols and reports with regard to software, processes and equipment
- Bachelor Degree in Scientific field
- 3+ Yrs Experience in QA Medical Devices
- Knowledge of: ISO13485 / CAPA / MDR / QMS systems
- Knowledge in the field of automation such as Exact and MS Office
- Dutch and English speaker