The ideal candidate has an extensive experience in software testing and quality assurance. This role involves establishing and following a comprehensive software testing plan, improving technical file traceability, and embedding a solid QA approach within the team. The candidate will bridge the gap between software testing (control/verification) and quality assurance (regulatory/validation), ensuring compliance with regulatory requirements.
Responsibilities
Develop and implement a comprehensive software testing plan, including both manual and automated testing processes.
Improve technical file traceability and ensure alignment with QMS requirements.
Envision and implement a robust QA approach within the team.
Implement a test-driven approach to development and risk-based assessments of features. Follow that approach in day-to-day testing and release activities.
Define the effort required to align existing processes with regulatory requirements, establish a robust regression test set and ensure proper linkage with the QMS.
Evaluate, select and implement appropriate test automation tools, followed by their qualification and validation.
Skills
Proven experience in software testing and quality assurance, particularly in the medical device industry.
Strong understanding of regulatory requirements and quality management systems (QMS).
Expertise in both manual and automated testing processes.
Ability to conduct risk-based assessments of features within a development team.
Proficiency in evaluating and selecting test automation tools, as well as their qualification and validation.
Excellent communication and collaboration skills to work effectively within a team.
Qualifications
Certification in software testing (e.g., ISTQB) or quality assurance.
Experience with regulatory standards such as ISO 13485 and IEC 62304 is a must.
Familiarity with Agile development methodologies
