Software Quality Assurance Professional
hace 2 semanas
At Institut Straumann AG, we are seeking a skilled Software Quality Assurance Professional to join our team.
About the CompanyWe 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- You will collaborate with Product Owners, development teams, and other stakeholders to understand product and testing objectives thoroughly.
- Taking ownership of both manual and automated testing activities, you will ensure communication of their status to stakeholders.
- 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.).
- As a key member of our team, you will write and/or review product and technical documentation, ensuring compliance with medical device development standards.
- You will participate in design reviews and follow the testing strategy and planning (functional, integration, performance).
- You will identify deviations, bugs, and system errors and analyze them in partnership with development teams during the triage process.
- Managing V&V documentation throughout the design to production phases, including review and approval processes, is a crucial aspect of this role.
- You will stay updated with V&V practices and applicable standards to ensure the adoption of best practices and processes.
- 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.
- You will analyze complex issues, assess the impact of design changes, and support best practices identified by technical leads.
- Supporting quality processes such as internal and supplier audits, CAPA management, and training is essential to your success in this role.
- You will use tools and software applications that are validated according to the computerized-system validation.
- Collaborating with Quality & Regulatory to maintain compliance with relevant regulations is a critical aspect of this position.
- 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).
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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