Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency, standardization and adoption of proven approaches across manufacturing teams.
Proactively identify and report technical issues, contributing to continuous improvement initiatives and providing constructive feedback to management.
Rather than running daily manual test execution yourself, you will define the verification strategy, test coverage, and evidence completeness while partnering closely with our dedicated remote Software TestEngineer who executes test suites, regressions, and formal test reports. Over your first six months, you will be systematically mentored and developed to be come fully competent in regulatory software documentation, design controls,FDA premarket expectations, and cybersecurity standards for connected medical systems.
Review the quality documents obtained during the handover of new products, including samples, inspection samples, inspection templates, customer requirements, etc., and convert them into mass production documents and samples.
Evaluate AI outputs through repeatable tests and human review. Cover incorrect or unsupported answers, inconsistent results, ambiguous requests, and unusual inputs.