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 computerizedsystem 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 62366-1;
• 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.