Senior QA Engineer

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

• Maintain the QMS in accordance with certification standards and ensure its evolution
• Lead quality improvements projects
• Provide the necessary support to the controllers in order to guarantee the relevance of the Quality decisions with regards to the requirements of the products
• Implementing product development requirements
• Support in the creation of test methods
• Monitoring of compliance with processes and standard

Requirements

• Bachelor’s degree in relevant field
• 5 years’ experience in Medical Device Industry
• Must have at least 5 years’ experience in ISO 13485 and IEC 62304
• Must have software knowledge in Medical Devices
• 5 years’ experience in the field of design, quality, quality management, quality assurance or in another regulated industry in compliance with regulation
• 3 years’ experience in risk management, ideally in medical technology
• Knowledge of the project management tools
• Very good knowledge of spoken and written English