ABOUT STRAUMANN
Headquartered in Basel, Straumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Having pioneered many of the most influential technologies and techniques in our field, we have a tradition of doing more to advance dental regeneration, restoration and replacement, as well as patient care.
Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape our future and create impact. Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations.
Main Tasks and Responsibilities: Collaborate with Product Owners, development teams, and other stakeholders to understand product and testing objectives thoroughly;Take ownership of both manual and automated testing activities, ensuring communication of their status to stakeholders;Design, maintain, and execute test specifications and automated scripts for Verification & Validation (V&V), adhering to documentation practices required for medical device software development (compliant with IEC 62304, ISO 13485, etc.);Write and/or review product and technical documentation, ensuring compliance with medical device development standards;Participate in design reviews and follow the testing strategy and planning (functional, integration, performance);Identify deviations, bugs and system errors and analyze them in partnership with development teams during the triage process;Manage V&V documentation throughout the design to production phases, including review and approval processes;Stay updated with V&V practices and applicable standards to ensure the adoption of best practices and processes;Participate in the planning and analysis of new functionalities to be developed in an Agile way contributing to the software requirements review with the product owner and the software developer;Analyze complex issues, assess the impact of design changes, and support best practices identified by technical leads;Support quality processes such as internal and supplier audits, CAPA management, and training;Use tools and software applications that are validated according to the computerized-system validation;Collaborate with Quality & Regulatory to maintain compliance with relevant regulations.Minimum Requirements: Bachelor of Engineering (computer, software, biomedical) or equivalent qualification and experience;Prior work experience in software quality assurance in/as medical device developed in an agile environment;Professional experience with standards ISO 13485, IEC 62304, IEC 62366-1;Knowledge of software QA methodologies, tools, and processes;Excellent analytical and problem-solving skills;Attention to detail;Good understanding of software development lifecycle and QA best practices;Ability to analyze and synthesize;Good communication skills for successful cross-functional collaboration both inside and outside of the team;Proficiency in using automated testing tools and frameworks is a plus;Any relevant certification (CTFL, CSQE, CSM, CSTE or CSQA) is a plus;Professional language skills (English and/or French).
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