Overview
Our client a global leading Medical Device Manufacturer based near Basel, Switzerland is looking for a Senior QA Engineer. This is an exciting role which involves life changing operations for the patients.
Responsibilities
Maintain the QMS in accordance with certification standards and ensure its evolution
Lead quality improvement projects
Provide necessary support to the controllers to guarantee the relevance of quality decisions with regards to product requirements
Implement product development requirements
Support in the creation of test methods
Monitor compliance with processes and standards
Requirements
Bachelor’s degree in a relevant field
5 years’ experience in the Medical Device Industry
Minimum 5 years’ experience in ISO 13485 and IEC 62304
Software knowledge in Medical Devices
5 years’ experience in design, quality, quality management, quality assurance, or another regulated industry in compliance with regulation
3 years’ experience in risk management, ideally in medical technology
Knowledge of project management tools
Very good knowledge of spoken and written English
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