Overview
Our client a global leading Medical Device Manufacture based near Basel, Switzerland is looking for Senior QA Engineer. This is an exciting role which involves life changing operations for the patients.
Responsibilities:
1. Maintain the QMS in accordance with certification standards and ensure its evolution
2. Lead quality improvements projects
3. Provide the necessary support to the controllers in order to guarantee the relevance of the
4. Quality decisions with regards to the requirements of the products
5. Implementing product development requirements
6. Support in the creation of test methods
7. Monitoring of compliance with processes and standard
Requirements:
8. Bachelor’s degree in relevant field
9. 5 years’ experience in Medical Device Industry
10. Must have at least 5 years’ experience in ISO 13485 and IEC 62304
11. Must have software knowledge in Medical Devices
12. 5 years’ experience in the field of design, quality, quality management, quality assurance or in another regulated industry in compliance with regulation
13. 3 years’ experience in risk management, ideally in medical technology
14. Knowledge of the project management tools
15. Very good knowledge of spoken and written English
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