Quality Assurance Officer
This company is a medical device company located in the area of Utrecht and one of the leading manufacturer of innovative custom made denture products.
As a QA Officer you will be responsible for the overal and cross-departmental processes related to quality assurance. You work together with our current QA Officer and report to the QARA Manager.
- Responsible for designing, maintaining, safeguarding and optimizing the quality system with the help of QMS software;
- Being constantly aware of (local) laws and regulations of countries where we are active (incl. 13485, MDR) and translate this into the quality system;
- Responsible for registering, investigating and reporting internal and external complaints including trend analyzes.
- Responsible for coordinating, conducting and/ or supervising internal and external audits;
- Initiate corrective and preventative measures (CAPAs).
- Fluent in Dutch (is a must) and English;
- Min. 3 years of QA experience within the medical devices, aerospace, automotive;
- ISO 13485 training, Medical Devices ACT and internal auditor or repared to follow;
- HBO working and thinking level.