• Prepare detailed test plans and write test cases in preparation for development of major features based on product requirements. • Perform cross browser manual testing of new product features to catch bugs and defects. • Identify, document and track defects across our product backlog with detailed comprehensive reports. • Participate during sprint planning session and discuss your testing approach for each task with test cases to support this. • Communicate effectively with all members of development team throughout the development life cycle when reporting bugs. • Collaborate with our Web, API and Data teams to understand project requirements and provide quality assurance insights. • Conduct regression testing prior to a new release.

• Develop and execute comprehensive test strategies combining both manual and automated approaches • Create and maintain automated mobile UI tests using Maestro • Analyze network traffic with Charles Proxy • Contribute to automation strategy and CI/CD pipeline maintenance • Collaborate closely with development and product teams • Investigate and report bugs systematically • Participate in quality decisions and suggest process improvements • Evaluate existing testing scripts and frameworks to identify improvement areas

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role is responsible for ensuring the qualification, validation, and ongoing compliance of GxP-regulated systems, including eQMS platforms, third-party systems, and vendor-supplied software. The Quality Engineer, Systems & Compliance will manage vendor quality programs, internal audits, and regulatory readiness activities to support clinical operations. Working closely with IT, DevOps, and clinical teams, this position ensures systems are validated, compliant, and maintained in a state of inspection readiness. The role requires a strong understanding of FDA, ISO, and EU regulations, along with hands-on experience in system validation, vendor qualification, and audit management. You will have the opportunity to influence system compliance strategy while contributing to the continuous improvement of quality and regulatory processes in a collaborative, remote-friendly environment. - Lead qualification and validation of GxP-regulated systems, including eQMS, COTS, and TPS platforms, using risk-based methodologies aligned with GAMP 5 and FDA CSA guidance. - Develop, execute, and maintain validation plans, reports, UAT scripts, and traceability matrices while ensuring compliance with 21 CFR Part 11 and EU GMP Annex 11. - Administer and continuously improve eQMS workflows, including CAPA, deviations, NCRs, change controls, and document management. - Manage the Vendor Qualification Program and TPS audit schedule, including initial qualification, requalification, performance monitoring, and maintenance of approved vendor lists. - Lead internal and vendor audits end-to-end: planning, execution, reporting, and CAPA follow-up through verified closure. - Support sponsor audits and regulatory inspections by coordinating readiness, facilitating evidence collection, and tracking closure of findings. - Apply ALCOA+ data integrity principles to system records, validation documentation, and QMS content. Qualifications - Bachelor’s degree in Science, Engineering, IT, or related field (advanced degree preferred). - Active certified auditor credential (ASQ CQA, ISO Lead Auditor, or equivalent). - 5–8 years of experience in quality assurance within clinical trials, pharmaceutical, or medical device/SaMD environments. - Hands-on experience with GxP system validation using GAMP 5 and FDA CSA guidance, including IQ/OQ/PQ and UAT. - Proven expertise in vendor and third-party system qualification, audit execution, and CAPA management. - Experience administering eQMS platforms (e.g., Qualio, Greenlight Guru, Veeva Vault QMS, MasterControl). - Knowledge of 21 CFR Part 11, EU GMP Annex 11, ISO 13485, ICH E6(R3), and risk-based compliance methodologies. - Strong analytical, communication, and cross-functional collaboration skills. - Ability to work independently in a remote-first, regulated environment while maintaining inspection readiness. - Preferred: Experience applying Lean, Six Sigma, or other process improvement methodologies to QMS and validation workflows. Benefits - Competitive salary range: $95,000–$105,000 USD. - Remote-first work environment with flexible work practices. - Generous paid time off: 20 vacation days, 10 personal days, and 10 public holidays. - 401(k) matching up to 3% of annual salary. - Comprehensive health, dental, and vision coverage, fully employer-sponsored short-term and long-term disability, and life insurance. - Pre-tax benefits including healthcare and dependent care flexible spending accounts. - Learning and development opportunities, including mentorship and support for professional certifications. Company Description

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role offers a critical opportunity to ensure the integrity, reliability, and accuracy of enterprise data used across the organization. The Data QA Engineer will focus on validating data pipelines, transformations, analytics outputs, and BI reports, enabling the business to make confident, data-driven decisions. You will design and execute automated tests, implement monitoring frameworks, and perform targeted manual verifications, collaborating closely with Data Engineering and BI teams. The role requires a mix of technical expertise, analytical rigor, and strong problem-solving skills. You will influence data quality standards, improve testing frameworks, and contribute to best practices across projects. This is a remote role, providing flexibility while allowing you to engage in high-impact, mission-critical work. - Collaborate with engineering and BI teams to translate project requirements into comprehensive data quality test plans and validation criteria. - Develop, maintain, and execute automated tests for data pipelines, transformations, and analytics outputs, ensuring accuracy and reliability. - Write and optimize SQL queries for validations, reconciliation, business-rule checks, and regression testing. - Monitor and manage automated test runs and data observability alerts, ensuring timely detection of anomalies and schema changes. - Investigate and resolve data issues, tracing data lineage from source to reports, and validate fixes collaboratively with engineers. - Contribute to the continuous improvement of QA processes, frameworks, monitoring, and documentation of standards. - Mentor team members and lead high-impact QA initiatives, promoting knowledge sharing and adherence to best practices. Qualifications - Bachelor’s degree in Computer Science, Information Systems, or related field, or equivalent professional experience. - Minimum of 5+ years of experience in data quality, QA engineering, or a related data-focused role. - Strong expertise in SQL, Python, and test automation frameworks (e.g., Cypress, Great Expectations). - Experience with ETL/ELT pipelines, data models, and BI/reporting tools (e.g., Power BI, Tableau). - Proficiency with CI/CD pipelines, version control (e.g., Git), and Agile development practices. - Excellent analytical, problem-solving, and attention-to-detail skills. - Strong communication and collaboration skills to work effectively across cross-functional teams. - Preferred: Experience with data observability, monitoring, and automated alerting for pipeline health and anomaly detection. Requirements - Bachelor’s degree in Computer Science, Information Systems, or related field, or equivalent professional experience. - Minimum of 5+ years of experience in data quality, QA engineering, or a related data-focused role. - Strong expertise in SQL, Python, and test automation frameworks (e.g., Cypress, Great Expectations). - Experience with ETL/ELT pipelines, data models, and BI/reporting tools (e.g., Power BI, Tableau). - Proficiency with CI/CD pipelines, version control (e.g., Git), and Agile development practices. - Excellent analytical, problem-solving, and attention-to-detail skills. - Strong communication and collaboration skills to work effectively across cross-functional teams. - Preferred: Experience with data observability, monitoring, and automated alerting for pipeline health and anomaly detection. Benefits - Competitive salary: $100,000 – $130,000 USD, based on experience and expertise. - Fully remote work with all required technology provided. - Comprehensive healthcare benefits, including medical, dental, and vision coverage. - Paid time off, holidays, and parental leave. - Professional development opportunities, training, and mentorship programs. - Collaborative, quality-focused, and dynamic work environment with flexible workflows. - Opportunities to lead initiatives and influence data quality practices organization-wide.