Clinical QA Specialist

Elucid-posted about 1 year ago
Full-time • Mid Level
Remote • Boston, MA
Administrative and Support Services
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The Clinical QA Specialist at Elucid plays a vital role in ensuring that medical device software meets high standards of quality and compliance. This position involves designing and executing innovative test strategies, documenting defects, and collaborating with software development and SQA teams to resolve issues. The specialist will uphold the integrity and reliability of applications that contribute to better patient outcomes in cardiovascular care.

  • Act as a quality advocate for patient and physician needs within agile/scrum engineering teams.
  • Develop and execute product/process validation activities, including design of experiments and performance qualifications.
  • Create process/product monitoring and control activities based on validation results.
  • Develop design verification strategies and test plans with SQA to ensure clinical performance and correctness.
  • Understand patient risks and objectives, working towards those goals with Clinical and SQA teams.
  • Develop clinical specifications and acceptance criteria.
  • Document defects found during testing and troubleshoot issues.
  • Maintain documentation such as test protocols, reports, and work instructions to ensure ongoing clinical product performance.
  • Degree in Radiology Technology, Computer Science, Bioengineering, Biomedical Engineering or equivalent.
  • 3+ years of clinical QA experience, focusing on clinical or healthcare-related software.
  • Prior experience with medical imaging (CTA), medical devices, or in a regulated industry is preferred.
  • Excellent written and verbal communication skills, with the ability to translate technical context into mainstream language.
  • Strong experience using Jira.
  • Adaptable to work in a fast-paced startup environment.
  • Knowledge of cardiovascular disease and anatomy.
  • Hybrid work setting with in-person encouragement on Mondays and Wednesdays for Boston-area employees.
  • Equal opportunity employer with a commitment to diversity.
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