Piper Companies is seeking a Quality Investigator to join an eClinical Solutions Company located in Raleigh, NC and Malvern, PA through a hybrid work schedule. The Quality Investigator will be responsible for leading investigations into software defects, failures, and user-reported issues to determine root causes and drive quality improvements across our software systems. Responsibilities of the Quality Investigator include: * Collaborate with software developers, product managers, and customer support teams to gather relevant information and user feedback * Employ systematic problem-solving techniques such as Root Cause Analysis (RCA), Fault Tree Analysis (FTA), and Cause and Effect Diagrams * Develop detailed corrective and preventive action plans (CAPAs) to enhance software reliability * Document findings and recommendations in comprehensive investigation reports and present them to senior management * Monitor the implementation of solutions to ensure effectiveness and prevent recurrence * Stay current with new technologies and methodologies that could improve the investigation process or software quality * Assist in preparing for external audits and ensure compliance with industry standards such as ISO 9001, ISO/IEC 27001, ISO-8000, and Health Authority regulations * Qualifications for the Quality Investigator include: * 1-2 years of experience in software quality assurance or a related field * Strong analytical skills and proficiency in software diagnostic tools * Proficient in SQL and C# with a solid understanding of software development environments and issue resolution * Excellent written and verbal communication skills * High attention to detail with strong organizational and project management skills * Bachelor's degree in Computer Science, Software Engineering, or a related field (or equivalent internship experience) * Hybrid: Onsite 1-2 days a month in Raleigh, NC or Malvern, PA * Must be eligible to work in the United States Compensation and Benefits for the Quality Investigator include: * Salary Range: $70,000 - $90,000 annually, depending on experience * Comprehensive benefits package, 401(k) with company match This job opens for applications on May 9th, 2025. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: quality assurance, software quality, software testing, root cause analysis, CAPA, ISO 9001, ISO/IEC 27001, ISO-8000, software diagnostics, SQL, C#, software development lifecycle, SDLC, defect tracking, software reliability, audit preparation, regulatory compliance, clinical trials, biotech, pharmaceutical software, quality improvement, fault tree analysis, RCA, FTA, CAPA development, investigation reports, software validation, QA engineer, software issue resolution, software compliance, risk management, documentation, technical writing, software bugs, quality systems, GxP, validation protocols, software traceability, agile QA, software metrics, continuous improvement, quality control, software process improvement #LI-JB1 #LI-HYBRID