Software Quality Assurance Professional

hace 2 semanas


Madrid, Madrid, España Institut Straumann AG A tiempo completo

At Institut Straumann AG, we are seeking a skilled Software Quality Assurance Professional to join our team.

About the Company

We are a global leader in implant and restorative dentistry and oral tissue regeneration. Our company has a proud history of pioneering innovations and a tradition of advancing dental regeneration, restoration, and replacement, as well as patient care.

Main Responsibilities
  1. You will collaborate with Product Owners, development teams, and other stakeholders to understand product and testing objectives thoroughly.
  2. Taking ownership of both manual and automated testing activities, you will ensure communication of their status to stakeholders.
  3. You will 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.).
  4. As a key member of our team, you will write and/or review product and technical documentation, ensuring compliance with medical device development standards.
  5. You will participate in design reviews and follow the testing strategy and planning (functional, integration, performance).
  6. You will identify deviations, bugs, and system errors and analyze them in partnership with development teams during the triage process.
  7. Managing V&V documentation throughout the design to production phases, including review and approval processes, is a crucial aspect of this role.
  8. You will stay updated with V&V practices and applicable standards to ensure the adoption of best practices and processes.
  9. In an Agile environment, you will participate in the planning and analysis of new functionalities to be developed, contributing to the software requirements review with the product owner and the software developer.
  10. You will analyze complex issues, assess the impact of design changes, and support best practices identified by technical leads.
  11. Supporting quality processes such as internal and supplier audits, CAPA management, and training is essential to your success in this role.
  12. You will use tools and software applications that are validated according to the computerized-system validation.
  13. Collaborating with Quality & Regulatory to maintain compliance with relevant regulations is a critical aspect of this position.
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.
  • A good understanding of software development lifecycle and QA best practices.
  • The 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).
Compensation and Benefits

We offer a competitive salary of approximately $80,000 - $110,000 per year, depending on qualifications and experience. In addition to a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off, we also provide opportunities for professional growth and development.



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