Software Quality Analyst

vor 1 Woche

Berlin, Berlin, Deutschland Straumann Vollzeit 60.000 € - 90.000 € pro Jahr

Headquartered in Basel, Switzerland, Straumann is a global leader in implant and restorative dentistry and oral tissue regeneration. We have a proud tradition of pioneering innovations that advance dental regeneration, restoration, and patient care. Straumann partners with passionate people who thrive in our agile, size-for-success environment and value the opportunity to shape our future.

Key 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.

Qualifications

  • 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 ;
  • Knowledge of software QA methodologies, Agile Testing, tools, and processes;
  • Excellent analytical and problem-solving skills;
  • Attention to detail;
  • Good understanding of software development lifecycle and QA good 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 English language skills;
  • Good knowledge of German.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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