Full Time Taiwan TY

【DET QARA】 Software Quality Engineer

 

【Main Responsibilities】
• Establish software testing plans to deliver quality for medical software intended uses, safety, and security
• Responsible for developing and maintaining software testing pipelines for automatic or manual testing to improve software quality
• Responsible to review software tool validation to ensure the tools used in product development, test and operation processes are fully validated to fulfill intended uses
• Align with customer quality governance model for design & development projects
• Provide guidance to project team members on processes & template requirements, and reviewing software design deliverables

【Required Skills & Qualifications】
• Bachelor’s degree or higher in Computer Science or Engineering
• 2+ years in a Software/firmware Development Quality Assurance role
• Fluent in C/C++, or C#, python programming language
• Experienced in building up software system/functional/integration test cases and analyzing architecture/module interaction between software components
• Experienced in development Quality/testing role in medical device industry is a plus
• Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (EU:MDR, IEC62304, ISO13485, ISO14971, UL2900) is preferred
• Result oriented, Team player, pragmatic & pro-active
• Good at English listening/speaking/reading/writing

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