This international Medical Device company is located nearby Gouda. They are active in the Medical Device industry. Since this company is going internationally they expand their department.
You will help out the QA/RA Director to set up a plan and create a full focus on QA related questions for this organisation and will responsible about the Audits and Validation. You will be also in charge for internal QMS.
- Complete quality investigation and product risk assessment for product disposition
- Facilitate and support in audits
- Implementation of the Quality Management System– CAPA/Deviations/Internal Audits/Complaints – in line with procedures and regulatory requirements
- Conduct and implementation of the internal Audit programme
- In charge over the Internal and external Audits
- Can work independent when necessary
- 5-6 Yrs experience in QA position to work independently
- Managing experience in a QA environment
- B.S. or B.A. in Engineering, Medical Device or other related discipline
- Knowledge of applicable foreign and domestic regulations
- Finished ISO 13485 courses, ISO 14971 is a plus
- Knowledge of resource planning and project management skills
- Problem Solving, Analysing and hands on mindset and Attention to detail