Position Overview We are seeking a Software Quality Assurance and Compliance Specialist to establish and lead the quality framework for our biomedical imaging informatics software solutions. This role is responsible for the design, implementation, and continuous improvement of both our software validation program and our Quality Management System (QMS), ensuring compliance with international regulatory requirements and industry best practices.
The Specialist will oversee the full software validation lifecycle—including requirements management, test design, coding and automation, execution, remediation, and documentation—while embedding quality processes across the organization. The role will partner closely with product development, clinical, operations, and regulatory teams to ensure our imaging software products are validated, secure, and reliable for use in regulated research and clinical trial environments worldwide.
Regulatory frameworks relevant to this role include FDA 21 CFR Part 11, GxP, EMA Annex 11, ISO 27001 Provide QA leadership during external inspections, customer audits, and certification activities.

QUALIFICATIONS

• Bachelor’s degree in Computer Science, Biomedical Engineering, Life Sciences, or related field; advanced degree preferred.
• 12+ years of progressive experience in software quality assurance, with at least 5 years in a leadership role within biomedical imaging, medical devices, or regulated life sciences software.
• Strong hands-on experience in test script writing, automated testing frameworks, and coding for QA purposes.
• Expertise with Katalon Studio, Selenium or similar test management tools.
• Proficient in scripting or programming languages used in QA automation (e.g., Java, Python, Groovy, or JavaScript).
• Leading the QA team to drive successful validation and deployment of all products while contributing to the product strategy and the overall product roadmap
• Familiarity with imaging modalities (MRI, CT, PET, etc.) and imaging informatics standards (DICOM, HL7, FHIR) strongly preferred.
• Proven expertise with regulatory guidelines (GxP, 21 CFR Part 11, HIPPA, GDPR and familiar with FDA QSR, ISO 13485, ISO 14971, IEC 62304, ISO/IEC 27001).
• Demonstrated experience maintaining a company wide quality management system.
• Demonstrated success leading QA organizations through audits.
• Strong leadership, communication, and collaboration skills, with the ability to influence across functions and geographies.
• Experience implementing modern QA practices, including automation, DevOps, and risk-based testing approaches.
• Experience in the software release lifecycle and producing and delivering client release packages.

• Strategy & Leadership
• Develop and implement the overall QA strategy inclusive of people, process, and technology, aligning with business objectives, product strategy, and regulatory requirements.
• Lead, mentor, and grow a global QA team responsible for software verification, validation, automation, and compliance testing.
• Contribute to the product roadmap by ensuring QA alignment with business goals and successful product deployment.
• Foster strong collaboration between Software Development, IT, Operations, Clinical, Regulatory, and QA teams.
• Establish quality metrics and dashboards to monitor product quality, process efficiency, and compliance health.
• Act as the voice for quality across the organization, fostering a culture of excellence and continuous improvement.
• Quality Systems & Compliance
• Own and maintain the software quality system, including SOPs, design controls, risk management processes, validation cycle documentation, and audit readiness.
• Ensure compliance with FDA, EMA, and other global regulations (e.g GxP, 21 CFR Part 11, ISO 9001, HIPAA, GDPR).
• Direct QA activities throughout the development and change control lifecycle, from new feature implementation to release management.
• Ensure compliance with internal SOPs, external standards, and partner specifications, maintaining readiness for audits and inspections.
• Handle systems that may contain Protected Health Information (PHI) or other sensitive data securely and in compliance with privacy regulations.
• Testing & Validation
• Architect, implement, and maintain automated continuous testing frameworks and CI/CD pipelines that enable high-quality, reliable deliverables.
• Oversee the design, development, documentation, and installation of product validation systems, processes, and procedures for biomedical imaging informatics software.
• Develop, review, and approve validation plans, test protocols, and release packages supporting the software development lifecycle.
• Manage software testing methodologies for imaging platforms, ensuring accuracy, reproducibility, scalability, usability, security, and cybersecurity resilience.
• Create and oversee execution of unit, component, integration, acceptance, load, security, scalability, usability, and platform tests.
• Develop and maintain detailed test scripts, automated test cases, and regression test suites using Katalon Studio, Selenium, or equivalent test management tools.
• Collaborate with software engineers to establish robust coding practices, version control, and unit testing standards.
• Confirm all feasible tests are executed within the automated testing framework.
• Ensure that all product defects are logged, tracked, and resolved within the project lifecycle.
• Operations & Resource Management
• Allocate QA resources effectively across projects to meet objectives and timelines.
• Direct quality assurance, testing, and compliance for client systems and imaging platforms.
• Establish and track QA metrics and dashboards to evaluate team performance, product quality, and progress toward goals.
• Continuous Improvement & Professional Development
• Evaluate progress and results of QA activities, continuously improving processes and practices for efficiency and quality.
• Maintain technical expertise in product validation, test engineering, and automation.
• Drive innovation in QA by assessing and implementing new tools, automation approaches, and methodologies.